|
Table of Exempted Prescription Products
|
||||||
| September 25, 2023 | ||||||
| Drug Enforcement Administration | ||||||
| Diversion Control Division | ||||||
| Drug and Chemical Evaluation Section | ||||||
|
Exempt Prescription Products
|
9/25/2023 | |||||
| Company | Trade Name | NDC Code | Form | Controlled Substance |
(mg or mg/ml)
|
|
| Acella Pharmaceuticals, LLC | Chlordiazepoxide HCl and Clidinium Bromide Capsules | 42192-0336 | CA | Chlordiazepoxide HCl | 5 | |
| Actavis Pharma, Inc. | Butalbital, Acetaminophen and Caffeine Capsules USP 50/300/40 | 0591-2640 | CA | Butalbital | 50 | |
| Actavis Pharma, Inc. | Butalbital, Acetaminophen and Caffeine Tablets USP 50/325/40 | 0591-3369 | TB | Butalbital | 50 | |
| Actavis Pharma, Inc. | Fioricet (Butalbital, Acetaminophen and Caffeine USP 50/300/40) | 52544-080 | CA | Butalbital | 50 | |
| Alpha Scriptics Inc | Butacet Capsules | 53121-0133 | CA | Butalbital | 50 | |
| Alphagen Laboratories, Inc. | Butalbital and Acetaminophen Capsules 50 mg/ 650 mg | 00603-2542 | CA | Butalbital | 50 | |
| Alphagen Laboratories, Inc. | Geone Capsules | 59743-0004 | CA | Butalbital | 50 | |
| Alphagen Laboratories, Inc. | Donnaphen Tablets | 59743-0027 | TB | Phenobarbital | 16.2 | |
| Altana, Inc. | Axocet (Butalbital and Acetaminophen) | 0281-0389 | TB | Butalbital | 50 | |
| Althon Pharmaceuticals, Inc. | Butalbital, Acetaminophen and Caffeine Tablets USP | 66813-074 | TB | Butalbital | 50 | |
| Alvogen, Inc. | Butalbital and | AcetaminophenTablets USP 50/325 | 47781-0535 | TB | Butalbital | 50 |
| Alvogen, Inc. | Butalbital, Acetaminophen and Caffeine Tablets USP 50/325/40 | 47781-0536 | TB | Butalbital | 50 | |
| Alvogen, Inc. | Butalbital, Acetaminophen and Caffeine Tablets (50/325/40) | 47781-0625 | TB | Butalbital | 50 | |
| Alvogen, Inc. | Butalbital and Acetaminophen Tablets 50/325 | 47781-0628 | TB | Butalbital | 50 | |
| Alvogen, Inc. | Butalbital and Acetaminophen Tablets (50/300) | 47781-0644 | TB | Butalbital | 50 | |
| American Pharmaceuticals, Inc. | AMERICET Tablets | 58605-0501 | TB | Butalbital | 50 | |
| American Urologicals Inc | Butace | 00539-0906 | CA | Butalbital | 50 | |
| Amerisource Health Services Corporation | Chlordiazepoxide HCl and Clidinium Bromide Capsules | 60687-0639 | CA | Chlordiazepoxide HCl | 5 | |
| Amerisource Health Services Corporation | Butalbital, Acetaminophen and Caffeine Tablets 50/325/40 mg | 68084-0396 | TB | Butalbital | 50 | |
| Amide Pharmaceuticals | BEL-PHEN-ERGOTS Tablets | 00182-1990 | TB | Phenobarbital | 40 | |
| Amide Pharmaceuticals | Phenerbel-S Tablets | 00536-4234 | TB | Phenobarbital | 40 | |
| Amide Pharmaceuticals | Bellaspas Tablets | 00603-2424 | TB | Phenobarbital | 40 | |
| Amide Pharmaceuticals | DuraGal-S Tablets | 51285-0907 | TB | Phenobarbital | 40 | |
| Amide Pharmaceuticals | Chlordiazepoxide HCl and Clidinium Bromide Capsules | 52152-0018 | CA | Chlordiazepoxide HCl | 5 | |
| Amide Pharmaceuticals | Theophedrital Tablets | 52152-0035 | TB | Phenobarbital | 8 | |
| Amide Pharmaceuticals | Bellamine-S Tablets | 52152-0115 | TB | Phenobarbital | 40 | |
| Amneal Pharaceuticals, LLC. | Chlordiazepoxide HCl and Clidinium Bromide Capsules 5 mg/2.5 mg | 60219-1677 | CA | Chlordiazepoxide HCl | 5 | |
| Anabolic Laboratories, Inc | Spastrin Tablets | 51991-045 | TB | Phenobarbital | 40 | |
| Aphena Pharma Solutions | Butalbital, Acetaminophen and Caffeine Tablets (50/325/40 mg) | 71610-0042 | TB | Butalbital | 50 | |
| Apotheca | Theophen | 12634-0101 | TB | Phenobarbital | 8 | |
| Apothecon Florida | Phenobarbital with Belladonna Alkaloids Tablets | 72768-7010 | TB | Phenobarbital | 16.2 | |
| Apothecon Florida | Phenobarbital with Belladonna Alkaloids Oral Solution (Grape) | 72768-9011 | LQ | Phenobarbital | 16.2 | |
| Apothecon Florida | Phenobarbital with Belladonna Alkaloids Oral Solution (Mint) | 72768-9012 | LQ | Phenobarbital | 16.2 | |
| Arco Pharmaceuticals | Arco-Lase Plus | 00275-0045 | TB | Phenobarbital | 8 | |
| Arlo Interamerican | Espasmotex | 11475-0835 | TB | Phenobarbital | 20 | |
| Ascend Laboratories, LLC | Chlordiazepoxide HCl and Clidinium Bromide Capsules | 67877-731 | CA | Chlordiazepoxide HCl | 5 | |
| Ascher and Co | Anaspaz PB | 00225-0300 | TB | Phenobarbital | 15 | |
| Ascot Pharmaceuticals | Antispasmodic Tablets | 47679-0158 | TB | Phenobarbital | 16.2 | |
| Ascot Pharmaceuticals | Chlordiazepoxide Hydrochloride + Clidinium Bromide | 47679-0268 | CA | Chlordiazepoxide HCl | 5 | |
| Page 1 | ||||||
|
Exempt Prescription Products
|
9/25/2023 | |||||
| Company | Trade Name | NDC Code | Form | Controlled Substance |
(mg or mg/ml)
|
|
| Atland Pharmaceuticals | Butalbital and Acetaminophen Tablets (25 mg/325 mg) | 71993-301 | TB | Butalbital | 25 | |
| Atlantic Biologicals Corp. | Phenohytro Elixir, Grape Flavor | 17856-0125 | EL | Phenobarbital | 32.4 | |
| Atlantic Biologicals Corp. | Donnatal Elixir-Grape | 17856-0423 | EL | Phenobarbital | 3.24 | |
| Atley Pharmaceuticals | Butalbital, Acetaminophen and Caffeine Tablets | 59702-661 | TB | Butalbital | 50 | |
| Aurobindo Pharma Inc. | Butalbital, Acetaminophen and Caffeine Capsules USP 50/325/40 | 13107-075 | CA | Butalbital | 50 | |
| AvKare, Inc | (Manuf. by Belcher Pharmaceuticals, LLC) | Chlordiazepoxide Hydrochloride /Clidinium Bromide 5 mg/2.5 mg | 42291-214 | CA | Chlordiazepoxide HCl | 5 |
| AvKare, Inc | (Manuf. by IriSys Inc.) | Donnatal Elixir | 42291-244 | EL | Phenobarbital | 3.24 |
| AvKare, Inc | (Manuf. by IriSys Inc.) | Donnatal Tablets | 42291-245 | TB | Phenobarbital | 16.2 |
| AvKare, Inc. | Butalbital, Acetaminophen and Caffeine Capsules USP 50/300/40 | 42291-181 | CA | Butalbital | 50 | |
| AvKare, Inc. | Phenobarbital with Belladonna Alkaloids Elixir | 42291-205 | EL | Phenobarbital | 16.2 | |
| AvKare, Inc. | Butalbital, Acetaminophen and Caffeine Tablets USP 50/325/40 | 50268-139 | TB | Butalbital | 50 | |
| Ayerst Laboratories | PMB-200 | 00046-0880 | TB | Meprobamate | 200 | |
| Ayerst Laboratories | PMB-400 | 00046-0881 | TB | Meprobamate | 400 | |
| Barre Drug Co | Isolate Compound | 00472-0929 | EL | Phenobarbital | 0.4 | |
| Barre Drug Co | Barophen | 00472-0981 | EL | Phenobarbital | 3.24 | |
| Baucum Laboratories Inc | Butalbital, Acetaminophen and Caffeine Tablets | 54696-0513 | TB | Butalbital | 50 | |
| Beecham Laboratories | Hybephen | 00029-2360 | TB | Phenobarbital | 15 | |
|
Belcher Pharmaceuticals (Manufactured for Avet Pharma)
|
Chlordiazepoxide Hydrochloride /Clidinium Bromide 5 mg/2.5 mg | 23155-808 | CA | Chlordiazepoxide HCl | 5 | |
|
Belcher Pharmaceuticals (Manufactured for Misemer Pharm)
|
Chlordiazepoxide Hydrochloride /Clidinium Bromide 5 mg/2.5 mg | 0276-0500 | CA | Chlordiazepoxide HCl | 5 | |
|
Belcher Pharmaceuticals (Manufactured for Virtus Pharma)
|
Chlordiazepoxide Hydrochloride /Clidinium Bromide 5 mg/2.5 mg | 69543-453 | CA | Chlordiazepoxide HCl | 5 | |
|
Belcher Pharmaceuticals (Manufactured for Virtus Pharma)
|
Chlordiazepoxide Hydrochloride /Clidinium Bromide 5 mg/2.5 mg | 76439-302 | CA | Chlordiazepoxide HCl | 5 | |
|
Belcher Pharmaceuticals (Manufactured for Xiromed, LLC)
|
Chlordiazepoxide Hydrochloride /Clidinium Bromide 5 mg/2.5 mg | 70700-185 | CA | Chlordiazepoxide HCl | 5 | |
|
Bi-Coastal Pharma International (Manuf. By Winder Labs LLC)
|
Chlordiazepoxide Hydrochloride /Clidinium Bromide 5 mg/2.5 mg | 42582-301 | CA | Chlordiazepoxide HCl | 5 | |
| Bioline Labs Inc | Anti-Spas Tablets | 00719-1091 | TB | Phenobarbital | 16.2 | |
| Bioline Labs Inc | Chlordinium | 00719-1208 | CA | Chlordiazepoxide HCl | 5 | |
| Bioline Labs Inc | Bel-Phen-Ergot-S Tablets | 00719-1686 | TB | Phenobarbital | 40 | |
| Bioline Labs Inc | Anti-Spas Elixir | 00719-4090 | EL | Phenobarbital | 3.24 | |
| Bio-Pharm Inc. | Migercet-PB Suppository | 00144-0633 | SU | Pentobarbital | 60 | |
| Bio-Pharm Inc. | Ergocaff-PB Suppository | 00182-7007 | SU | Pentobarbital | 60 | |
| Bio-Pharm Inc. | Ergocaff-PB Suppository | 59741-0315 | SU | Pentobarbital | 60 | |
| Bio-Pharm Inc. | E-Caff-PB Suppository | 59879-0501 | SU | Pentobarbital | 60 | |
| BioRamo, LLC. | Phenobarbital, Hyoscyamine,Atropine, & Scopolamine Oral Solution | 54932-211 | LQ | Phenobarbital | 16.2 | |
| BioRamo, LLC. | Phenobarbital, Hyoscyamine,Atropine, & Scopolamine Oral Solution | 54932-212 | LQ | Phenobarbital | 16.2 | |
| Blaine Co | Spaslin | 00165-0029 | TB | Phenobarbital | 16.2 | |
| Blansett Pharm Co | Anolor 300 Capsules | 51674-0009 | CA | Butalbital | 50 | |
| Bock Pharmacal Co | Broncholate | 00563-0277 | CA | Phenobarbital | 8 | |
| Bowman Pharmaceutical | Private Formula No 3095 | 00252-3095 | TB | Phenobarbital Sodium | 15 | |
| Brandywine Pharmaceuticals LLC. | Chlordiazepoxide HCl and Clidinium Bromide Capsules 5 mg/2.5 mg | 71321-700 | CA | Chlordiazepoxide HCl | 5 | |
| Breon Labs | Isuprel Compound | 00057-0874 | EL | Phenobarbital | 0.4 | |
| Page 2 | ||||||
| Exempt Prescription Products | 9/25/2023 | |||||
| Company | Trade Name | NDC Code | Form | Controlled Substance | (mg or mg/ml) | |
| Bryant Ranch Prepack (BRP Pharmaceuticals) | Chlordiazepoxide HCl and Clidinium Bromide Capsules 5 mg/2.5 mg | 63629-2021 | CA | Chlordiazepoxide HCl | 5 | |
| Bryant Ranch Prepack (BRP Pharmaceuticals) | Phenobarbital and Belladonna Alkaloids Tablets | 63629-2050 | TB | Phenobarbital | 16.2 | |
| Bryant Ranch Prepack (BRP Pharmaceuticals) | Phenobarbital and Belladonna Alkaloids Elixir | 63629-2051 | EL | Phenobarbital | 16.2 | |
| Bryant Ranch Prepack (BRP Pharmaceuticals) | Phenobarbital and Belladonna Alkaloids Elixir | 63629-2052 | EL | Phenobarbital | 16.2 | |
| Bryant Ranch Prepack (BRP Pharmaceuticals) | Chlordiazepoxide HCl and Clidinium Bromide Capsules 5 mg/2.5 mg | 63629-2146 | CA | Chlordiazepoxide HCl | 5 | |
| Bryant Ranch Prepack (BRP Pharmaceuticals) | Chlordiazepoxide HCl and Clidinium Bromide Capsules 5 mg/2.5 mg | 63629-2373 | CA | Chlordiazepoxide HCl | 5 | |
| Bryant Ranch Prepack (BRP Pharmaceuticals) | Chlordiazepoxide HCl and Clidinium Bromide Capsules 5 mg/2.5 mg | 63629-8859 | CA | Chlordiazepoxide HCl | 5 | |
| Bryant Ranch Prepack (BRP Pharmaceuticals) | Chlordiazepoxide HCl and Clidinium Bromide Capsules 5 mg/2.5 mg | 72162-1237 | CA | Chlordiazepoxide HCl | 5 | |
| Bryant Ranch Prepack (BRP Pharmaceuticals) | Chlordiazepoxide HCl and Clidinium Bromide Capsules 5 mg/2.5 mg | 71335-9764 | CA | Chlordiazepoxide HCl | 5 | |
| Caldwell & Bloor Co | Hyosital White | 00361-2131 | TB | Phenobarbital | 16.2 | |
| Cameron Pharmaceuticals, LLC. | Chlordiazepoxide HCl and Clidinium Bromide Capsules 5 mg/2.5 mg | 42494-409 | CA | Chlordiazepoxide HCl | 5 | |
| Cardinal Health | Butalbital, Acetaminophen and Caffeine Tablets 50mg/325mg/40mg | 0904-6538 | TB | Butalbital | 50 | |
| Cardinal Health | Butalbital, Acetaminophen and Caffeine Tablets 50mg/325mg/40mg | 55154-3356 | TB | Butalbital | 50 | |
| Cardinal Health | Butalbital, Acetaminophen and Caffeine Tablets 50mg/325mg/40mg | 55154-3356 | TB | Butalbital | 50 | |
| Cardinal Health | Butalbital, Acetaminophen and Caffeine Tablets 50mg/325mg/40mg | 55154-7147 | TB | Butalbital | 50 | |
| Cardinal Health | Butalbital, Acetaminophen and Caffeine Tablets 50mg/325mg/40mg | 55154-7988 | TB | Butalbital | 50 | |
| Carnrick Labs Inc | Phrenilin | 00086-0050 | TB | Butalbital | 50 | |
| Carpenter Pharmacal Co | ALAGESIC Tablets | 55726-0300 | TB | Butalbital | 50 | |
| Chartwell RX Sciences, LCC | Chlordiazepoxide HCl and Clidinium Bromide Capsules 5 mg/2.5 mg | 62135-696 | CA | Chlordiazepoxide HCl | 5 | |
| Chelsea Laboratories | Chlordiazepoxide with Clidinium Bromide | 46193-0948 | CA | Chlordiazepoxide HCl | 5 | |
| Cody Laboratories, Inc | BU-TAB AC | 65893-100 | TB | Butalbital | 50 | |
| Columbia Drug Co | Isopap Capsules | 11735-0400 | CA | Butalbital | 50 | |
| Concordia Pharmaceuticals Inc. | Donnatal Elixir-Mint Flavored | 59212-0422 | EL | Phenobarbital | 3.24 | |
| Concordia Pharmaceuticals Inc. | Donnatal Elixir-Grape Flavored | 59212-0423 | EL | Phenobarbital | 3.24 | |
| Concordia Pharmaceuticals Inc. | Donnatal Tablets | 59212-0425 | TB | Phenobarbital | 16.2 | |
| Consolidated Midland | Bellalphen | 00223-0425 | TB | Phenobarbital | 16.2 | |
| Contract Pharmacal Corp. | Pyrelle HB | 66663-702-01 | TB | Butabarbital | 15 | |
| CTEX Pharmaceuticals, Inc. | Butex Forte Capsules | 62022-0070 | CA | Butalbital | 50 | |
| CTEX Pharmaceuticals, Inc. | Butex Forte Capsules | 62022-0074 | CA | Butalbital | 50 | |
| D.M. Graham Laboratories, Inc. | Butalbital, Acetaminophen and Caffeine Tablets | 00756-0111 | TB | Butalbital | 50 | |
| D.S.C. Laboratories | MICOMP-PB Suppository | 55053-0290 | SU | Pentobarbital USP | 60 | |
| Diversified Health Care Services | Geone Capsules | 59743-004 | CA | Butalbital | 50 | |
| Dorasol Laboratories | Donalixir | 00471-0095 | EL | Phenobarbital | 3.24 | |
| Dr. Reddy’s Laboratories, Inc. | Chlordiazepoxide HCl and Clidinium Bromide Capsules 5 mg/2.5 mg | 43598-706 | CA | Chlordiazepoxide HCl | 5 | |
| Dunhall Pharmacal Inc | Triaprin | 00217-2811 | CA | Butalbital | 50 | |
| Duramed Pharmaceuticals | Butalbital, Acetaminophen and Caffeine Tablets | 51285-0849 | TB | Butalbital | 50 | |
| ECI Pharmaceuticals, LLC | Chlordiazepoxide HCl and Clidinium Bromide Capsules 5 mg/2.5 mg | 51293-607 | CA | Chlordiazepoxide HCl | 5 | |
| ECI Pharmaceuticals, LLC | Phenobarbital, Hyoscyamine, Atropine, and Scopolamine Tablets | 51293-665 | TB | Phenobarbital | 16.2 | |
| ECI Pharmaceuticals, LLC | Chlordiazepoxide HCl and Clidinium Bromide Capsules 5 mg/2.5 mg | 51293-696 | CA | Chlordiazepoxide HCl | 5 | |
| Page 3 | ||||||
| Exempt Prescription Products | 9/25/2023 | |||||
| Company | Trade Name | NDC Code | Form | Controlled Substance | (mg or mg/ml) | |
| Econolab | Micomp-PB Tablets | 55053-0525 | TB | Pentobarbital Sodium | 30 | |
| EconoMed Pharmaceuticals, Inc. | ARCET Compound Tablets | 38130-0111 | TB | Butalbital | 50 | |
| EconoMed Pharmaceuticals, Inc. | ARCET Capsules | 38130-0325 | CA | Butalbital | 50 | |
| Elge, Inc. | Mednatal Elixer | 51285-0735 | EL | Phenobarbital | 16.2 | |
| Elge, Inc. | MICOMP-PB Suppositories | 55053-0290 | SU | Pentobarbital | 60 | |
| Elge, Inc. | Donnaphen Elixer | 58298-0432 | EL | Phenobarbital | 16.2 | |
| Equipharm Corp | EQUI-CET Tablets | 57779-0111 | TB | Butalbital | 50 | |
| Everett Laboratories, Inc | Repan Tablets | 00642-0162-10 | TB | Butalbital | 50 | |
| Everett Laboratories, Inc | Repan Capsules | 00642-0163 | CA | Butalbital | 50 | |
| Everett Laboratories, Inc | Repan Capsules | 00642-0164 | CA | Butalbital | 50 | |
| Forest Pharmacal Inc | G.B.S. | 00456-0281 | TB | Phenobarbital | 8 | |
| Forest Pharmacal Inc | Soniphen | 00456-0429 | ET | Phenobarbital | 16 | |
| Forest Pharmacal Inc | Bancap | 00456-0546 | CA | Butalbital | 50 | |
| Forest Pharmacal Inc | Esgic Tablets | 00456-0630 | TB | Butalbital | 50 | |
| Forest Pharmacal Inc | Esgic Capsules | 00456-0631 | CA | Butalbital | 50 | |
| Forest Pharmacal Inc | Acetaminophen 500 mg/Butalbital 50 mg | 00456-0671 | TB | Butalbital | 50 | |
| Forest Pharmacal Inc | Acetaminophen 325 mg/Butalbital 50 mg | 00456-0674 | TB | Butalbital | 50 | |
| Forest Pharmacal Inc | ESGIC-PLUS | 00456-0678 | TB | Butalbital | 50 | |
| Forest Pharmacal Inc | ESGIC PLUS Capsules | 00456-0679 | CA | Butalbital | 50 | |
| Genetco Inc | Butalbital, Apap and Caffeine | 00302-0490 | TB | Butalbital | 50 | |
| Geneva Generics | Phenobarbital, Ergotamine and Belladonna Tablets | 00781-1701 | TB | Phenobarbital | 40 | |
| Geneva Pharmaceuticals, Inc. | T.E.P. Tablets | 00781-1325 | TB | Phenobarbital | 8 | |
| Geneva Pharmaceuticals, Inc. | Butalbital, Acetaminophen and Caffeine Tablets | 00781-1901 | TB | Butalbital | 50 | |
| Gen-King Products | Antispasmodic | 03547-0777 | TB | Phenobarbital | 16.2 | |
| Geriatric Pharmacal Corp | Bilezyme Plus | 00249-1112 | TB | Phenobarbital | 8 | |
| Geriatric Pharmacal Corp | Gustase Plus | 00249-1121 | TB | Phenobarbital | 8 | |
| Glenlawn Laboratories | Chlordinium Sealets | 00580-0084 | CA | Chlordiazepoxide HCl | 5 | |
| GM Pharmaceuticals (Manufactured by Mikart, Inc.) | Vanatol S (Butalbital, Acetaminophen, & Caffeine Soln 50/325/40 | 58809-359 | LQ | Butalbital | 50 | |
| GM Pharmaceuticals (Manufactured by Mikart, Inc.) | Vanatol LQ (Butalbital, Acetaminophen, & Caffeine Soln 50/325/40 | 58809-820 | LQ | Butalbital | 50 | |
| Goldline Laboratories | Antispasmodic Tablets | 00182-0129 | TB | Phenobarbital | 16.2 | |
| Goldline Laboratories | Antispasmodic Elixir | 00182-0686 | EL | Phenobarbital | 3.24 | |
| Goldline Laboratories | Tedrigan Tablets | 00182-1002 | TB | Phenobarbital | 8 | |
| Goldline Laboratories | Butalbital, APAP and Caffeine Tablets | 00182-1274 | TB | Butalbital | 50 | |
| Goldline Laboratories | Bel-phen-ergot s Tablets | 00182-1847 | TB | Phenobarbital | 40 | |
| Goldline Laboratories | CDP Plus Capsules | 00182-1856 | CA | Chlordiazepoxide HCL | 5 | |
| Granules Pharmaceuticals Inc. | Butalbital, Acetaminiphen and Caffeine Capsules 50mg/300mg/40mg | 70010-044 | CA | Butalbital | 50 | |
| Granules Pharmaceuticals Inc. | Butalbital and Acetaminiphen Capsules 50 mg/300 mg | 70010-054 | CA | Butalbital | 50 | |
| GSMS Incorporated | Butalbital, Acetaminophen and Caffeine Capsules USP (50/300/40) | 51407-200 | CA | Butalbital | 50 | |
| GSMS Incorporated | Butalbital, Acetaminophen and Caffeine Tablets USP (50/325/40) | 60429-589 | TB | Butalbital | 50 | |
| Page 4 | ||||||
| Exempt Prescription Products | 9/25/2023 | |||||
| Company | Trade Name | NDC Code | Form | Controlled Substance | (mg or mg/ml) | |
| Halsey Drug Co Inc | Susano | 00879-0058 | TB | Phenobarbital | 16.2 | |
| Halsey Drug Co Inc | Susano | 00879-0059 | EL | Phenobarbital | 3.24 | |
| Halsey Drug Co Inc | Clinoxide | 00879-0501 | CA | Chlordiazepoxide HCl | 5 | |
| Halsey Drug Co Inc | Butalbital and Acetaminophen Tablets | 00879-0543 | TB | Butalbital | 50 | |
| Halsey Drug Co Inc | Blue Cross Butalbital, APAP and Caffeine Tablets | 00879-0567 | TB | Butalbital | 50 | |
| HL Moore | Chlordiazepoxide HCl and Clidinium Bromide Capsules | 00839-6211 | CA | Chlordiazepoxide Hydrochloride | 5 | |
| HL Moore Drug Exchange | Antispasmodic Tablets | 00839-5055 | TB | Phenobarbital | 16 | |
| HL Moore Drug Exchange | Theophenyllin | 00839-5111 | TB | Phenobarbital | 8 | |
| HL Moore Drug Exchange | Bellamor Tablets | 00839-7370 | TB | Phenobarbital | 40 | |
| Hyrex Pharmaceutical | Panzyme | 00314-0310 | TB | Phenobarbital | 8.1 | |
| Hyrex Pharmaceutical | Two-Dyne Revised | 00314-2229 | TB | Butalbital | 50 | |
| Ingenus Pharmaceuticals, LLC. | Phenobarbital, Hyoscyamine, Atropine, and Scopolamine Mint Elixir | 50742-665 | EL | Phenobarbital | 16.2 | |
| Ingenus Pharmaceuticals, LLC. | Phenobarbital, Hyoscyamine, Atropine, and Scopolamine Grape Elixir | 50742-666 | EL | Phenobarbital | 16.2 | |
| Ingenus Pharmaceuticals, LLC. | Phenobarbital, Hyoscyamine, Atropine, and Scopolamine Tablets | 50742-667 | TB | Phenobarbital | 16.2 | |
| Integrity Pharmaceutical Corporation | Bellatal | 64731-0754 | TB | Phenobarbital | 16.2 | |
| International Ethical Laboratories, Inc. | Tencon Tablets | 11584-029-01 | TB | Butalbital | 50 | |
| Interstate Drug Exchange | IDE-Cet Tablets | 00814-3820 | TB | Butalbital | 50 | |
| Interstate Drug Exchange | Spastolate | 00814-7088 | TB | Phenobarbital | 16.2 | |
| Intetlab | CON-TEN | 11584-1029 | CA | Butalbital | 50 | |
| Inwood Laboratories, Inc. | Butalbital, Acetaminophen and Caffeine Tablets, USP | 0258-3657 | TB | Butalbital | 50 | |
| JMI-Canton Pharmaceuticals, Inc. | Belladonna Alkaloids and Phenobarbital Tablets | 00182-1048 | TB | Phenobarbital | 16.2 | |
| JMI-Canton Pharmaceuticals, Inc. | Hyonatal-PB | 52604-6792 | TB | Phenobarbital | 16.2 | |
| Kaiser Foundation Hospitals | Donnatal Elixir | 00179-0088 | EL | Phenobarbital | 16.2 | |
| Kaiser Foundation Hospitals | Donnatal Tablet | 00179-0132 | TB | Phenobarbital | 16.2 | |
| Keene Pharmacal Inc | Endolar | 00588-7777 | CA | Butalbital | 50 | |
| kenco | Axotal | 00013-1301 | TB | Butalbital | 50 | |
| Knoll Pharmaceutical | Quadrinal Tablets | 00044-4520 | TB | Phenobarbital | 24 | |
| Knoll Pharmaceutical | Quadrinal Suspension | 00044-4580 | SS | Phenobarbital | 2.4 | |
| Kraft Pharmacal Co Inc | Digestokraft | 00796-0237 | TB | Butabarbital Sodium | 8 | |
| Kremers Urban Co | Levsin with Phenobarbital Tablets | 00091-3534 | TB | Phenobarbital | 15 | |
| Kremers Urban Co | Levsinex with Phenobarbital | 00091-3539 | XC | Phenobarbital | 45 | |
| Kremers Urban Co | Levsin with Phenobarbital Elixir | 00091-4530 | EL | Phenobarbital | 3 | |
| Kremers Urban Co | Levsin-PB | 00091-4536 | DP | Phenobarbital | 15 | |
| KVK Tech | Butalbital, Acetaminophen & Caffeine Tablets (50mg/325mg/40mg) | 10702-253 | TB | Butalbital | 50 | |
| Landry Pharmacal Inc | Febridyne Plain Capsules | 05383-001 | CA | Butalbital | 50 | |
| Lannett Company, Inc. | Butalbital, Acetaminophen & Caffeine Tablets (50mg/325mg/40mg) | 00527-1695 | TB | Butalbital | 50 | |
| Lannett Company, Inc. | Butalbital, Acetaminophen & Caffeine Capsules (50mg/325mg/40mg) | 00527-4094 | CA | Butalbital | 50 | |
| Lannett Company, Inc. | Butalbital, Acetaminophen & Caffeine Capsules (50mg/300mg/40mg) | 00527-4095 | CA | Butalbital | 50 | |
| Lanpar Co | PB Phe-Bell | 12908-7006 | TB | Phenobarbital | 16.2 | |
| Page 5 | ||||||
|
Exempt Prescription Products
|
||||||
| Company | Trade Name | NDC Code | Form | Controlled Substance | ||
| Larken Laboratories, Inc. | Butalbital and Acetaminophen Tablets (50 mg/325 mg) | 68047-721 | TB |
Butalbital
|
||
| Larken Laboratories, Inc. | Butalbital and Acetaminophen Tablets (25 mg/325 mg) | 68047-722 | TB |
Butalbital
|
||
| Larken Laboratories, Inc. | Allzital Butalbital and Acetaminophen Tablets (25 mg/325 mg) | 68047-752 | TB |
Butalbital
|
||
| Lasalle Laboratories | Pacaps Modified Formula | 48534-0884 | CA |
Butalbital
|
||
| Lazarus Pharmaceuticals, Inc. | Phenobarbital and Belladonna Alkaloids Tablets | 71914-162 | TB |
Phenobarbital
|
||
| Lazarus Pharmaceuticals, Inc. | Phenobarbital and Belladonna Alkaloids Elixir | 71914-162 | EL |
Phenobarbital
|
||
| Lehigh Valley Technologies, Inc. | Phenazopyridine Plus | 51881-251 | TB |
Butabarbital
|
||
| Lemmon Company | Acetaminophen/Butalbital/Caffeine Tablets | 00093-0854 | TB |
Butalbital
|
||
| Lemmon Pharmacal Co | Donphen | 00093-0205 | TB |
Phenobarbital
|
||
| LGM Pharma Solutions, LLC | Butalbital, Acetaminophen and Caffeine Capsules (50/300/40 mg) | 79739-7029 | CA |
Butalbital
|
||
| LGM Pharma Solutions, LLC | Butalbital and Acetaminophen Tablets (50/300 mg) | 79739-7075 | TB |
Butalbital
|
||
| LGM Pharma Solutions, LLC | Butalbital, Acetaminophen and Caffeine Tablets (50/325/40 mg) | 79739-7320 | TB |
Butalbital
|
||
| Libertas Pharma, Inc. | Butalbital, Acetaminophen and Caffeine Capsules USP | 51862-179 | CA |
Butalbital
|
||
| Life Laboratories | Belladonna Alkaloids with Phenobarbital | 00737-1283 | EL |
Phenobarbital
|
||
| Lunsco Inc | Pacaps Capsules | 10892-0116 | CA |
Butalbital
|
||
| Major Pharmaceuticals | Theotal Tablets | 00904-0774 | TB |
Phenobarbital
|
||
| Major Pharmaceuticals | Cafatine-PB Tablets | 00904-1750 | TB |
Pentobarbital Sodium
|
||
| Major Pharmaceuticals | Bellamine Tablets | 00904-2548 | TB |
Phenobarbital
|
||
| Major Pharmaceuticals | Fabophen Tablets | 00904-3280 | TB |
Butalbital
|
||
| Major Pharmaceuticals | Belladona w/ Phenobarbital | 00904-3741 | TB |
Phenobarbital
|
||
| Major Pharmaceuticals | Butalbital, Acetaminophen and Caffeine Tablets | (50/325/40mg) | 0904-6938 | TB |
Butalbital
|
|
| Mallard Consumer Products | Anaquan Tablets | 59441-0343 | TB |
Butalbital
|
||
| Mallard Inc | Malatal | 00166-0748 | TB |
Phenobarbital
|
||
| Mallard Inc | Anoquan Modified Formula | 00166-0881 | CA |
Butalbital
|
||
| Mallinckrodt Inc. | Butalbital, Acetaminophen, and Caffeine (“BAC”) Tablets USP | 00406-0970 | TB |
Butalbital
|
||
| Marlop Pharmacal Inc | Broncomar | 12939-0128 | EL |
Butabarbital
|
||
| Marlop Pharmacal Inc | Dolmar | 12939-0812 | CA |
Butalbital
|
||
| Marnel Pharmaceuticals | Margesic Capsules | 00682-0804 | CA |
Butalbital
|
||
| Marnel Pharmaceuticals | Marten-Tab Tablets | 00682-1400 | TB |
Butalbital
|
||
| Martec Pharmacal Inc | Butalbital, Acetaminophen and Caffeine Tablets | 52555-0079 | TB |
Butalbital
|
||
| Mayne Pharma | Butalbital, Acetaminophen, & Caffeine Capsules 50/300/40 | 51862-542 | CA |
Butalbital
|
||
| Mayrand Pharmaceuticals, Inc | Sedapap-10 Tablets | 00259-1278 | TB |
Butalbital
|
||
| Mead Johnson Pharmacal | Quibron Plus Elixir | 00087-0511 | EL |
Butabarbital
|
||
| Mead Johnson Pharmacal | Quibron Plus Capsules | 00087-0518 | CA |
Butabarbital
|
||
| Medco Supply Co | Phenobarbital & Hyoscyamine Sulfate | 00764-2057 | TB |
Phenobarbital
|
||
| Medicopharma, Inc. | DUO-SPAZ Capsules | 53404-0350 | CA |
Chlordiazepoxide
|
||
| Merrell Pharmaceuticals Inc. | Chlordiazepoxide HCl and Clidinium Capsules | 00536-3490 | CA |
Chlordiazepoxide HCl
|
||
| Micro Labs USA, Inc | Chlordiazepoxide HCl and Clidinium Bromide Capsules, USP | 42571-381 | CA |
Chlordiazepoxide HCl
|
||
| Midlothian Laboratories (Manufactured by Mikart, Inc.) | Esgic (Butalbital, Acetaminophen, & Caffeine Capsules 50/325/40 | 68308-219 | CA |
Butalbital
|
||
| Page 6 | ||||||
|
Exempt Prescription Products
|
||||||
| Company | Trade Name | NDC Code | Form | Controlled Substance | ||
| Midlothian Laboratories (Manufactured by Mikart, Inc.) | Esgic (Butalbital, Acetaminophen, & Caffeine Tablets 50/325/40 | 68308-220 | TB |
Butalbital
|
||
| Midlothian Laboratories (Manufactured by Mikart, Inc.) | Zebutal (Butalbital, Acetaminophen, & Caffeine Capsules 50/325/40 | 68308-554 | CA |
Butalbital
|
||
| Mikart, Inc. | Bupap | 00095-0240 | TB |
Butalbital
|
||
| Mikart, Inc. | Butalbital, Acetaminophen and Caffeine Tablets USP | 00258-3665 | TB |
Butalbital
|
||
| Mikart, Inc. | Sedapap Tablets | 00259-0392 | TB |
Butalbital
|
||
| Mikart, Inc. | Esgic Tablets | 00535-0011 | TB |
Butalbital
|
||
| Mikart, Inc. | Esgic Capsules | 00535-0012 | CA |
Butalbital
|
||
| Mikart, Inc. | Butalbital, Acetaminophen and Caffeine Capsules | 00588-7788 | CA |
Butalbital
|
||
| Mikart, Inc. | Butalbital, Acetaminophen and Caffeine Tablets, USP | 0591-3416 | TB |
Butalbital
|
||
| Mikart, Inc. | Butalbital and Acetaminophen Tablets 50/650 | 11584-0029 | TB |
Butalbital
|
||
| Mikart, Inc. | Tencon (Butalbital and Acetaminophen 50mg/325mg) | 11584-0030 | TB |
Butalbital
|
||
| Mikart, Inc. | DOLMAR Tablets | 12939-0811 | TB |
Butalbital
|
||
| Mikart, Inc. | Butalbital, Acetaminophen and Caffeine Tablets | 46672-0053 | TB |
Butalbital
|
||
| Mikart, Inc. | Butalbital, Acetaminophen, and Caffeine Tablets | 46672-0059 | TB |
Butalbital
|
||
| Mikart, Inc. | Butalbital and Acetaminophen Tablets 50/650 | 46672-0098 | TB |
Butalbital
|
||
| Mikart, Inc. | Butalbital and Acetaminophen Tablets 50/325 | 46672-0099 | TB |
Butalbital
|
||
| Mikart, Inc. | Butalbital, Acetaminophen and Caffeine Capsules | 46672-0228 | CA |
Butalbital
|
||
| Mikart, Inc. | Butalbital, Acetaminophen and Caffeine Eilixer | 46672-0633 | EL |
Butalbital
|
||
| Mikart, Inc. | Butalbital, Acetaminophen and Caffeine Tablets, USP | 46672-184 | TB |
Butalbital
|
||
| Mikart, Inc. | Butalbital and Acetaminophen Capsules 50/300 | 46672-286 | CA |
Butalbital
|
||
| Mikart, Inc. | Butalbital and Acetaminophen Tablets 50/300 | 46672-856 | TB |
Butalbital
|
||
| Mikart, Inc. | Butalbital, Acetaminophen and Caffeine Tablets USP | 49884-0811 | TB |
Butalbital
|
||
| Mikart, Inc. | Alagesic Capsules | 50991-302 | CA |
Butalbital
|
||
| Mikart, Inc. | Butalbital, Acetaminophen, and Caffeine Tablets | 51432-0034 | TB |
Butalbital
|
||
| Mikart, Inc. | Butalbital, Acetaminophen and Caffeine Tablets USP (50/325/40) | 51862-540 | TB |
Butalbital
|
||
| Mikart, Inc. | Butalbital, Acetaminophen and Caffeine Tablets | 52555-0647 | TB |
Butalbital
|
||
| Mikart, Inc. | Capacet (Butalbital, Acetaminophen, and Caffeine | 50/325/40) | 58407-534 | CA |
Butalbital
|
|
| Mikart, Inc. | Promacet | 58605-524 | TB |
Butalbital
|
||
| Mikart, Inc. | Cephadyn Tablets | 59702-0650 | TB |
Butalbital
|
||
| Mikart, Inc. | Dolgic Tablets | 62022-0073 | TB |
Butalbital
|
||
| Mikart, Inc. | Butalbital, Acetaminophen, and Caffeine Oral Solution | 66813-073 | LQ |
Butalbital
|
||
| Mikart, Inc. | Dolgic Plus Tablets | 68453-074 | TB |
Butalbital
|
||
| Mikart, Inc. (on behalf of Mayne Pharma) | Butalbital and Acetaminophen Tablets 50/300 | 51862-538 | TB |
Butalbital
|
||
| Mikart, Inc. (on behalf of Mayne Pharma) | Butalbital and Acetaminophen Capsules 50/300 | 51862-544 | CA |
Butalbital
|
||
| Mikart, Inc. (on behalf of Monarch PCM, LLC) | Vtol LQ (Butalbital, Acetaminophen, Caffeine Oral Solution) | 70154-111 | LQ |
Butalbital
|
||
| Mikart, Inc./Shionogi, Inc. | Dolgic Plus Tablets | 59630-074 | TB |
Butalbital
|
||
| Moore Medical Corporation | Antispasmodic Tabs | 00839-5055 | TB |
Phenobarbtal
|
||
| Moore Medical Corporation | Butalbital, Acetaminophen and Caffeine Tablets | 00839-7831 | TB |
Butalbital
|
||
| Morton Grove Pharmaceuticals, Inc. | Antispasmodic Elixir | 60432-0009 | EL |
Phenobarbital
|
||
| Page 7 | ||||||
| Exempt Prescription Products | 9/25/2023 | |||||
| Company | Trade Name | NDC Code | Form | Controlled Substance | (mg or mg/ml) | |
| Nejo Pharmaceutical | Spasmalones | 00653-0002 | TB | Phenobarbital | 16 | |
| Nexgen Pharma | BUPAP (Butalbital and Acetaminophen 50mg/300mg) | 0095-3000 | TB | Butalbital | 50 | |
| Nexgen Pharma | Butalbital with Acetaminophen and Caffeine Tablets | 0722-7029 | TB | Butalbital | 50 | |
| Nexgen Pharma | Butalbital, Acetaminophen and Caffeine Tablets(50mg/325mg/40mg) | 0722-7320 | TB | Butalbital | 50 | |
| Northampton Medical, Inc. | FEMCET | 58436-0703 | TB | Butalbital | 50 | |
| NorthStar | Butalbital, Acetaminophen and Caffeine Capsules(50mg/300mg/40mg) | 16714-170 | CA | Butalbital | 50 | |
| Oceanside Pharmaceuticals (Manufactured by Nexgen) | Butalbital and Acetaminophen Tablets (50mg/300mg) | 68682-306 | TB | Butalbital | 50 | |
| Parke-Davis & Co | Tedral SA | 00071-0231 | XT | Phenobarbital | 25 | |
| Parke-Davis & Co | Dilantin with Phenobarbital 1/4 | 00071-0375 | CA | Phenobarbital | 16 | |
| Parke-Davis & Co | Dilantin with Phenobarbital 1/2 | 00071-0531 | CA | Phenobarbital | 32 | |
| Parmed Pharmaceutical | Sedapar Tablets | 00349-2355 | TB | Phenobarbital | 16.2 | |
| Parmed Pharmaceutical | Sedapar Elixir | 00349-4100 | EL | Phenobarbital | 3.24 | |
| Pasadena Research | Seds | 00418-4072 | TB | Phenobarbital | 16.2 | |
| PD-Rx Pharmaceuticals, Inc. | Donnatal Tablets | 43063-601 | TB | Phenobarbital | 16.2 | |
| PD-Rx Pharmaceuticals, Inc. | Butalbital/APAP/Caffeine Tablets (50mg/325mg/40mg) | 55289-0879 | TB | Butalbital | 50 | |
| Pecos Pharmaceuticals | Phenobel Extentabs | 59879-0110 | TB | Phenobarbital USP | 48.6 | |
| Pernix Therapeutics | Chlordiazepoxide HCL/ Clidinium Bromide Capsules | 44183-0401 | CA | Chlordiazepoxide HCl | 5 | |
| Pharmaceutical Associates, Inc (PAI Pharma) | Donnatal Elixir-Grape Flavored | 66689-063 | EL | Phenobarbital | 3.24 | |
| Pharmaceutical Basics Inc | Clinibrax Capsules | 00832-1054 | CA | Chlordiazepoxide HCl | 5 | |
| Pharmaceutical Basics Inc | Butalbital, Acetaminophen and Caffeine Tablets | 00832-1102 | TB | Butalbital | 50 | |
| PharmaTech LLC (Manufactured for Virtus Pharmaceutical) | Chlordiazepoxide HCL and Clidinium Bromide Capsules | 76439-302 | CA | Chlordiazepoxide HCl | 5 | |
| Phlight Pharma, LLC. | Allzital (Butalbital and Acetaminophen Tablets (25 mg/325 mg)) | 70569-150 | TB | Butalbital | 25 | |
| Pioneer Pharmaceuticals, Inc. | Chlordiazepoxide HCL/ Clidinium Bromide Capsules | 60104-4009 | CA | Chlordiazepoxide HCl | 5 | |
| Poly Pharmaceuticals, Inc. | Alagesic | 50991-0302 | CA | Butalbital | 50 | |
| Poythress & Co Inc | Antrocol Tablets | 00095-0040 | TB | Phenobarbital | 16 | |
| Poythress & Co Inc | Antrocol | 00095-0041 | CA | Phenobarbital | 16 | |
| Poythress & Co Inc | Antrocol Elixir | 00095-0042 | EL | Phenobarbital | 3 | |
| Poythress & Co Inc | Mudrane | 00095-0050 | TB | Phenobarbital | 8 | |
| Poythress & Co Inc | Mudrane GG Tablets | 00095-0051 | TB | Phenobarbital | 8 | |
| Poythress & Co Inc | Mudrane GG Elixir | 00095-0053 | EL | Phenobarbital | 0.5 | |
| Prasco Laboratories | Phenobarbital, Hyoscyamine, Atropine, Scopolamine Tablets | 66993-117 | TB | Phenobarbital | 16.2 | |
| Prasco Laboratories | Phenobarbital, Hyoscyamine, Atropine, Scopolamine Elixir (Grape) | 66993-118 | EL | Phenobarbital | 16.2 | |
| Prasco Laboratories | Phenobarbital, Hyoscyamine, Atropine, Scopolamine Elixir (Mint) | 66993-119 | EL | Phenobarbital | 16.2 | |
| Private Formula Inc | Sangesic | 00511-1627 | TB | Butalbital | 30 | |
| ProficientRx | Butalb/Acet/Caffeine 50mg/325mg/40mg | 63187-933 | TB | Butalbital | 50 | |
| ProficientRx | Butalb/Acet/Caffeine 50mg/325mg/40mg | 71205-510 | TB | Butalbital | 50 | |
| ProficientRx | Butalb/Acet/Caffeine 50mg/300mg/40mg | 71205-962 | CA | Butalbital | 50 | |
| ProficientRx | Butalb/Acet/Caffeine 50mg/325mg/40mg | 71205-981 | TB | Butalbital | 50 | |
| Qualitest Pharmaceuticals, Inc. | Butalbital and Acetaminophen Tablets | 0603-2540 | TB | Butalbital | 50 | |
| Page 8 | ||||||
| Exempt Prescription Products | 9/25/2023 | |||||
| Company | Trade Name | NDC Code | Form | Controlled Substance | (mg or mg/ml) | |
| Qualitest Pharmaceuticals, Inc. | Butalbital, Acetaminophen and Caffeine Tablets 50/325/40mg | 0603-2544 | TB | Butalbital | 50 | |
| Qualitest Pharmaceuticals, Inc. | Butalbital, Acetaminophen and Caffeine Tablets USP | 0603-2547 | TB | Butalbital | 50 | |
| Qualitest Pharmaceuticals, Inc. | Butalbital, Acetaminophen and Caffeine Tablets, USP | 0603-2551 | TB | Butalbital | 50 | |
| Qualitest Pharmaceuticals, Inc. | Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules | 0603-2714 | CA | Chlordiazepoxide | 5 | |
| Qualitest Products Inc | Chlordiazepoxide HCl 5 mg and Clidinium Br 2.5 mg | 52446-0096 | CA | Chlordiazepoxide HCl | 5 | |
| Qualitest Products Inc | Butalbital, Acetaminophen and Caffeine Tablets | 52446-0544 | TB | Butalbital | 50 | |
| RECRO Pharma Inc. dba IRISYS(manuf. for Ingenus Pharm.) | Phenobarbital, Hyoscyamine, Atropine, and Scopolamine Mint Elixir | 50742-665 | EL | Phenobarbital | 3.24 | |
| RECRO Pharma Inc. dba IRISYS(manuf. for Ingenus Pharm.) | Phenobarbital, Hyoscyamine, Atropine, and Scopolamine Grape Elixir | 50742-666 | EL | Phenobarbital | 3.24 | |
| RECRO Pharma Inc. dba IRISYS(manuf. for Ingenus Pharm.) | Phenobarbital, Hyoscyamine, Atropine, and Scopolamine Tablets | 50742-667 | TB | Phenobarbital | 16.2 | |
| Redi-Med | Butalbital Compound Capsules | 53506-0103 | CA | Butalbital | 50 | |
| Richlyn Laboratories | Aminophylline & Phenobarbital Tablets | 00115-2154 | TB | Phenobarbital | 15 | |
| Richlyn Laboratories | Aminophylline & Phenobarbital | 00115-2156 | ET | Phenobarbital | 15 | |
| Richlyn Laboratories | Bellophen | 00115-2400 | TB | Phenobarbital | 16.2 | |
| Richlyn Laboratories | Spasmolin | 00115-4652 | TB | Phenobarbital | 15 | |
| Richwood Pharmaceutical Co., Inc. | Bellatal Tablets | 58521-0162 | TB | Phenobarbital, USP | 16.2 | |
| Roberts Pharmaceutical Corporation | Anoquan | 54092-0178 | TB | Butalbital | 50 | |
| Roberts Pharmaceutical Corporation | Tencet Tablets | 59441-0153 | TB | Butalbital | 50 | |
| Robins A H Co Inc | Donnatal Capsules | 00031-4207 | CA | Phenobarbital | 16.2 | |
| Robins A H Co Inc | Donnatal Extentabs | 00031-4235 | XT | Phenobarbital | 48.6 | |
| Robins A H Co Inc | Donnatal No 2 | 00031-4264 | TB | Phenobarbital | 32.4 | |
| Robins A H Co Inc | Donnazyme | 00031-4649 | ET | Phenobarbital | 8.1 | |
| Roche Labs | Menrium 5-2 | 00140-0023 | TB | Chlordiazepoxide | 5 | |
| Roche Labs | Menrium 5-4 | 00140-0024 | TB | Chlordiazepoxide | 5 | |
| Roche Labs | Menrium 10-4 | 00140-0025 | TB | Chlordiazepoxide | 10 | |
| Rondex Laboratories | Antispasmodic | 00367-4118 | TB | Phenobarbital | 16.2 | |
| Rotex Pharmaceuticals, Inc. | Rogesic Capsules | 31190-0008 | CA | Butalbital | 50 | |
| Ruckstuhl Co | Sedarex No 3 | 00144-1575 | TB | Phenobarbital | 16.2 | |
| Rugby Laboratories Inc | Ergocaff-PB Tablets | 00536-3801 | TB | Pentobarbital Sodium | 30 | |
| Rugby Laboratories Inc | Hyosophen Tablets | 00536-3920 | TB | Phenobarbital | 16.2 | |
| Rugby Laboratories Inc | Hyosophen Capsules | 00536-3926 | CA | Phenobarbital | 16 | |
| Rugby Laboratories Inc | ISOCET Tablets | 00536-3951 | TB | Butalbital | 50 | |
| Rugby Laboratories Inc | Theodrine Tablets | 00536-4648 | TB | Phenobarbital | 8 | |
| Rugby Laboratories Inc | Butalbital, Acetaminophen and Caffeine Tablets, USP | 0536-5567 | TB | Butalbital | 50 | |
| Russ Pharmaceuticals, Inc. | FEMCET Capsules | 50474-0703 | CA | Butalbital | 50 | |
| Sandoz Pharmaceuticals | Belladenal-S | 00078-0027 | XT | Phenobarbital | 50 | |
| Sandoz Pharmaceuticals | Belladenal | 00078-0028 | TB | Phenobarbital | 50 | |
| Sandoz Pharmaceuticals | Bellergal-S | 00078-0031 | XT | Phenobarbital | 40 | |
| Sandoz Pharmaceuticals | Cafergot P-B Suppository | 00078-0035 | SU | Pentobarbital | 60 | |
| Sandoz Pharmaceuticals | Cafergot P-B Tablets | 00078-0036 | TB | Pentobarbital Sodium | 30 | |
| Page 9 | ||||||
|
Exempt Prescription Products
|
||||||
| Company | Trade Name | NDC Code | Form | Controlled Substance | ||
| Savage Laboratories | AXOTAL | 00281-1301 | TB |
Butalbital
|
||
| Schein Henry Inc | Antispasmodic | 00364-0020 | TB |
Phenobarbital
|
||
| Schein Henry Inc | T-E-P | 00364-0266 | TB |
Phenobarbital
|
||
| Schein Henry Inc | Antispasmodic Elixir | 00364-7002 | EL |
Phenobarbital
|
||
| Schein Henry Inc |
Isolate Compound Elixir
|
00364-7029 | EL |
Phenobarbital
|
||
| Schein Pharmaceutical, Inc. |
Chlordiazepoxide HCl and Clidinium Bromide Capsules
|
00364-0559 | CA |
Chlordiazepoxide Hydrochloride
|
||
| Shoals Pharmaceuticals, Inc. | Tencet | 47649-0370 | TB |
Butalbital
|
||
| Shoals Pharmaceuticals, Inc. | Tencet Capsules | 47649-0560 | CA |
Butalbital
|
||
| Skylar Laboratories, LLC |
Butalbital and Acetaminophen Tablets (50 mg/325 mg)
|
70362-721 | TB |
Butalbital
|
||
| Skylar Laboratories, LLC |
Allzital (Butalbital and Acetaminophen Tablets) (25 mg/325 mg)
|
70362-722 | TB |
Butalbital
|
||
|
SOCIETAL CDMO San Diego, LLC (Manuf. for Concordia Pharm)
|
Donnatal Elixir-Mint Flavored
|
59212-0422 | EL |
Phenobarbital
|
||
|
SOCIETAL CDMO San Diego, LLC (Manuf. for Concordia Pharm)
|
Donnatal Elixir-Grape Flavored
|
59212-0423 | EL |
Phenobarbital
|
||
|
SOCIETAL CDMO San Diego, LLC (Manuf. for Concordia Pharm)
|
Donnatal Tablets | 59212-0425 | TB |
Phenobarbital
|
||
|
SOCIETAL CDMO San Diego, LLC (manuf. for Ingenus Pharm)
|
Phenobarbital, Hyoscyamine, Atropine, and Scopolamine Grape Elixir
|
50742-666 | EL |
Phenobarbital
|
||
|
SOCIETAL CDMO San Diego, LLC (manuf. for Ingenus Pharm)
|
Phenobarbital, Hyoscyamine, Atropine, and Scopolamine Tablets
|
50742-667 | TB |
Phenobarbital
|
||
|
SOCIETAL CDMO San Diego, LLC (manuf. for Ingenus Pharm)
|
Phenobarbital, Hyoscyamine, Atropine, and Scopolamine Mint Elixir
|
50742-665 | EL |
Phenobarbital
|
||
| Solubiomix |
Butalbital and Acetaminophen Tablets (50 mg/325 mg)
|
69499-302 | TB |
Butalbital
|
||
| Solubiomix |
Butalbital and Acetaminophen Capsules (50 mg/300 mg)
|
69499-342 | CA |
Butalbital
|
||
| Stewart Jackson Pharmacal, Inc. | Ezol | 45985-0578 | CA |
Butalbital
|
||
| STI Pharma, LLC |
Butalbital and Acetaminophen Tablets (50 mg/325 mg)
|
54879-026 | TB |
Butalbital
|
||
| Stuart Pharmaceutical | Kinesed | 00038-0220 | TB |
Phenobarbital
|
||
| Sunrise Pharmaceuticals, Inc. |
Butalbital, Acetaminophen, Caffeine Capsules (50 mg/300 mg/40mg)
|
11534-187 | CA |
Butalbital
|
||
| Sunrise Pharmaceuticals, Inc. |
Chlordiazepoxide HCl & Clidinium Bromide Caps USP (5mg/2.5mg)
|
11534-197 | CA |
Chlordiazepoxide HCl
|
||
| Superpharm Laboratories |
Chlordiazepoxide HCl & Clidinium Br
|
57247-1003 | CA |
Chlordiazepoxide HCl
|
||
| Taro Pharmaceuticals U.S.A., Inc. |
Butalbital, Acetaminophen and Caffeine Caps (50mg/300mg/40mg)
|
51672-4222 | CA |
Butalbital
|
||
| Tedor Pharma, Inc. |
Butalbital and Acetaminophen Tablets (50 mg/325 mg)
|
43199-053 | TB |
Butalbital
|
||
| Tedor Pharma, Inc. |
Butalbital and Acetaminophen Tablets (50 mg/300 mg)
|
47781-534 | TB |
Butalbital
|
||
| Tedor Pharma, Inc. (Manufactured | for Xspire Pharma) |
Butalbital, Acetaminophen and Caffeine Caps (50mg/300mg/40mg)
|
42195-955 | CA |
Butalbital
|
|
| Teva Pharmaceuticals |
Chlordiazepoxide HCl & Clidinium Bromide Caps USP (5mg/2.5mg)
|
11534-197 | CA |
Chlordiazepoxide HCl
|
||
| Towne Paulsen & Co | T.E. P. | 00157-0980 | TB |
Phenobarbital
|
||
| Trimen Labs |
Amaphen Capsules (reformulated)
|
11311-0954 | CA |
Butalbital
|
||
| Truxton C O Inc |
Atropine Sulfate with Phenobarbital
|
00463-6035 | TB |
Phenobarbital
|
||
| Truxton C O Inc |
Ephedrine with Phenobarbital
|
00463-6086 | TB |
Phenobarbital
|
||
| Truxton C O Inc | Spastemms Tablets | 00463-6181 | TB |
Phenobarbital
|
||
| Truxton C O Inc | Spastemms Elixir | 00463-9023 | EL |
Phenobarbital
|
||
| U.S. Pharmaceuticals | Medigesic Capsules | 52747-0600 | CA |
Butalbital
|
||
| UAD Laboratories Inc | Bucet Capsules | 00785-2307 | CA |
Butalbital
|
||
| UDL Laboratories |
Belladonna Alkaloids with Phenobarbital
|
51079-0168 | TB |
Phenobarbital
|
||
| United Research Laboratories, Inc. | Hapanol | 00677-0074 | TB |
Phenobarbital
|
||
| Page 10 | ||||||
| Exempt Prescription Products | 9/25/2023 | |||||
| Company | Trade Name | NDC Code | Form | Controlled Substance | (mg or mg/ml) | |
| United Research Laboratories, Inc. | Theophylline #1 Tablets | 00677-0148 | TB | Phenobarbital | 8 | |
| United Research Laboratories, Inc. | Bel-Tabs | 00677-1171 | TB | Phenobarbital | 40 | |
| United Research Laboratories, Inc. | Chlordiazepoxide HCl and Clidinium Bromide Capsules | 00677-1247 | CA | Chlordiazepoxide Hydrochloride | 5 | |
| University of Iowa | Bladder Mixture Plus Phenobarbital | 11326-1624 | LQ | Phenobarbital | 2.92 | |
| US Pharmaceuticals Inc | Medigesic Tablets | 52747-0311 | TB | Butalbital | 50 | |
| Vale Chemical Co | Ephedrine & Sodium Phenobarbital | 00377-0109 | TB | Phenobarbital Sodium | 16.2 | |
| Vale Chemical Co | Barbeloid (Revised) Green | 00377-0365 | TB | Phenobarbital | 16.2 | |
| Vale Chemical Co | Wesmatic Forte | 00377-0426 | TB | Phenobarbital | 8.1 | |
| Vale Chemical Co | Digestokraft | 00377-0460 | TB | Butabarbital Sodium | 8 | |
| Vale Chemical Co | Panzyme | 00377-0491 | TB | Phenobarbital | 8.1 | |
| Vale Chemical Co | Barbeloid Yellow | 00377-0498 | TB | Phenobarbital | 16.2 | |
| Vale Chemical Co | Charspast | 00377-0500 | TB | Phenobarbital | 16.2 | |
| Vale Chemical Co | Alkaloids of Belladonna and Phenobarbital | 00377-0527 | TB | Phenobarbital | 16.2 | |
| Vale Chemical Co | Truxaphen | 00377-0541 | TB | Phenobarbital | 16.2 | |
| Vale Chemical Co | Antispas | 00377-0622 | TB | Phenobarbital | 16.2 | |
| Vale Chemical Co | Wescophen S-II | 00377-0628 | TB | Phenobarbital | 30 | |
| Vale Chemical Co | Pulsaphen | 00377-0652 | TB | Phenobarbital | 15 | |
| Valeant Pharmaceuticals | Phrenilin Forte | 0187-0844 | CA | Butalbital | 50 | |
| Valeant Pharmaceuticals International | Librax (Chlordiazepoxide HCl and Clidinium Bromide) Capsules | 0187-4100 | CA | Chlordiazepoxide HCl | 5 | |
| Valeant Pharmaceuticals Intl./Oceanside Pharmaceuticals Inc. | Chlordiazepoxide HCl and Clidinium Bromide Capsules | 68682-409 | CA | Chlordiazepoxide HCl | 5 | |
| Victory Pharma Inc. (Manuf. By West-Ward Pharmaceutical) | Zebutal Brand Butalbital, Acetaminophen, and Caffeine Capsules | 68453-170 | CA | Butalbital | 50 | |
| Vintage Pharmaceuticals | Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules | 0254-2732 | CA | Chlordiazepoxide | 5 | |
| Vitarine Pharmaceuticals, Inc | E-Caff PB Tablets | 00185-0982 | TB | Pentobarbital | 30 | |
| Vortech Pharmacal Co | Phedral C. T. | 00298-1173 | TB | Phenobarbital | 8.1 | |
| Vortech Pharmacal Co | Hypnaldyne | 00298-1778 | TB | Phenobarbital | 16.2 | |
| Vortech Pharmacal Co | Donna-Sed | 00298-5054 | EL | Phenobarbital | 3.24 | |
| Vortech Pharmacal Co | Isophed | 00298-5680 | LQ | Phenobarbital | 0.4 | |
| Wallace Laboratories | Butibel Elixir | 00037-0044 | EL | Butabarbital Sodium | 3 | |
| Wallace Laboratories | Butibel Tablets | 00037-0046 | TB | Butabarbital Sodium | 15 | |
| Wallace Laboratories | Barbidonna Tablets | 00037-0301 | TB | Phenobarbital | 16 | |
| Wallace Laboratories | Barbidonna Elixir | 00037-0305 | EL | Phenobarbital | 3.2 | |
| Wallace Laboratories | Barbidonna No 2 | 00037-0311 | TB | Phenobarbital | 32 | |
| Wallace Laboratories | Lufyllin-EPG Tablets | 00037-0561 | TB | Phenobarbital | 16 | |
| Wallace Laboratories | Lufyllin-EPG Elixir | 00037-0565 | EL | Phenobarbital | 1.6 | |
| Wallace Laboratories | Milprem-400 | 00037-5401 | TB | Meprobamate | 400 | |
| Wallace Laboratories | Milprem-200 | 00037-5501 | TB | Meprobamate | 200 | |
| Warner Chilcott Laboratories | Pyridium Plus Tablets | 00430-0182 | TB | Butabarbital | 15 | |
| WE Hauck Inc | G-1 Capsules | 43797-0244 | CA | Butalbital | 50 | |
| Wesley Pharmacal Co | Pulsaphen Gray | 00917-0113 | TB | Phenobarbital | 15 | |
| Page 11 | ||||||
| Exempt Prescription Products | 9/25/2023 | |||||
| Company | Trade Name | NDC Code | Form | Controlled Substance | (mg or mg/ml) | |
| Wesley Pharmacal Co | Wescophen-S | 00917-0135 | TB | Phenobarbital | 30 | |
| Wesley Pharmacal Co | Hytrophen | 00917-0244 | TB | Phenobarbital | 16.2 | |
| Wesley Pharmacal Co | Wesmatic Forte | 00917-0845 | TB | Phenobarbital | 8 | |
| Westminster Pharmaceuticals | Butalbital, Acetaminophen and Caffeine Tablets(50mg/325mg/40mg) | 69367-203 | TB | Butalbital | 50 | |
| West-Ward Pharmaceutical Corp. | Butalbital, Acetaminophen, and Caffeine Tablets, USP | 00143-1115 | TB | Butalbital | 50 | |
| West-Ward Pharmaceutical Corp. | Belladonna Alkaloids & Phenobarbital | 00143-1140 | TB | Phenobarbital | 16.2 | |
| West-Ward Pharmaceutical Corp. | Theophylline Ephedrine & Phenobarbital | 00143-1695 | TB | Phenobarbital | 8 | |
| West-Ward Pharmaceutical Corp. | Butalbital with Acetaminophen and Caffeine Tablets | 00143-1787 | TB | Butalbital | 50 | |
| West-Ward Pharmaceutical Corp. | Butalbital, Acetaminophen and Caffein Capsules | 00143-3001 | CA | Butalbital | 50 | |
| West-Ward Pharmaceutical Corp. | Clindinax Capsules | 00143-3091 | CA | Chlordiazepoxide Hydrochloride | 5 | |
| West-Ward Pharmaceutical Corp. | Clindinax Capsules | 00143-3092 | CA | Chlordiazepoxide Hydrochloride | 5 | |
| West-Ward Pharmaceutical Corp. | Zebutal Brand Butalbital, Acetaminophen, and Caffeine Capsules | 59630-0170 | CA | Butalbital | 50 | |
| Winder Laboratories, LLC. | Phenohytro (Phenobarbital, Hyoscyamine, Atropine, Scopolamine) | 75826-118 | TB | Phenobarbital | 16.2 | |
| Winder Laboratories, LLC. | Phenohytro (Phenobarbital, Hyoscyamine, Atropine, Scopolamine) | 75826-127 | LQ | Phenobarbital | 16.2 | |
| Winder Laboratories, LLC. | Phenohytro (Phenobarbital, Hyoscyamine, Atropine, Scopolamine) | 75826-128 | LQ | Phenobarbital | 16.2 | |
| Winthrop Labs | Isuprel | 00024-0874 | EL | Phenobarbital | 0.4 | |
| Wraser Pharmaceuticals | Phrenilin Forte (Butalbital, Acetaminophen and Caffeine) 50/300/40 | 66992-955 | CA | Butalbital | 50 | |
| Zenith Goldline Pharmaceuticals | Belladonna Alkaloids with Phenobarbital ER Tablets | 00182-2611 | TB | Phenobarbital | 48.6 | |
| Zenith Goldline Pharmaceuticals | Butalbital, Acetaminophen and Caffeine Tablets | 00182-2659 | TB | Butalbital | 50 | |
| Page 12 |
