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What kinds of Chemical Ingredients are Included in Gabapentin?

Posted in Gabapentin

PRINCIPAL DISPLAY PANEL – 100 mg capsule bottle label

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 59762-5026-1
100 Capsules

GREENSTONE® BRAND

Gabapentin  capsules 100 mg

Rx only

PRINCIPAL DISPLAY PANEL – 300 mg capsule bottle label

ALWAYS DISPENSE WITH
MEDICATION GUIDE

NDC 59762-5027-1
100 Capsules

GREENSTONE® BRAND

Gabapentin
capsules

300 mg

Rx only

PRINCIPAL DISPLAY PANEL – 400 mg capsule bottle label

ALWAYS DISPENSE WITH
MEDICATION GUIDE

NDC 59762-5028-1
100 Capsules

GREENSTONE® BRAND

Gabapentin
capsules

400 mg

Rx only

PRINCIPAL DISPLAY PANEL – 600 mg tablet bottle label

ALWAYS DISPENSE WITH
MEDICATION GUIDE

NDC 59762-5023-1
100 Tablets

GREENSTONE® BRAND

Gabapentin
tablets

600 mg

Rx only

PRINCIPAL DISPLAY PANEL – 800 mg tablet bottle label

ALWAYS DISPENSE WITH
MEDICATION GUIDE

NDC 59762-5024-1
100 Tablets

GREENSTONE® BRAND

Gabapentin
tablets

800 mg

Rx only

PRINCIPAL DISPLAY PANEL – 470 mL Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 59762-5025-1
470 mL

GREENSTONE® BRAND

Gabapentin
oral solution

250 mg / 5 mL

Rx only

Gabapentin 
Gabapentin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:59762-5026
Route of AdministrationORALDEA Schedule
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Gabapentin (Gabapentin)Gabapentin100 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE
STARCH, CORN
TALC
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 2
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize16mm
FlavorImprint CodeG;5026
Contains
Packaging
#Item CodePackage Description
1NDC:59762-5026-1100 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA AUTHORIZED GENERICNDA02023512/30/1993
See also  When Was Gabapentin Approved by the U.S. Food and Drug Administration (FDA) ?
Gabapentin 
Gabapentin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:59762-5027
Route of AdministrationORALDEA Schedule
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Gabapentin (Gabapentin)Gabapentin300 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE
STARCH, CORN
TALC
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2
Product Characteristics
ColorYELLOWScoreno score
ShapeCAPSULESize19mm
FlavorImprint CodeG;5027
Contains
Packaging
#Item CodePackage Description
1NDC:59762-5027-1100 CAPSULE in 1 BOTTLE
2NDC:59762-5027-2500 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA AUTHORIZED GENERICNDA02023512/30/1993
Gabapentin 
Gabapentin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:59762-5028
Route of AdministrationORALDEA Schedule
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Gabapentin (Gabapentin)Gabapentin400 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE
STARCH, CORN
TALC
GELATIN
FERRIC OXIDE RED
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize22mm
FlavorImprint CodeG;5028
Contains
Packaging
#Item CodePackage Description
1NDC:59762-5028-1100 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA AUTHORIZED GENERICNDA02023512/30/1993
Gabapentin 
Gabapentin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:59762-5023
Route of AdministrationORALDEA Schedule
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Gabapentin (Gabapentin)Gabapentin600 mg
Inactive Ingredients
Ingredient NameStrength
POLOXAMER 407
STARCH, CORN
MAGNESIUM STEARATE
HYDROXYPROPYL CELLULOSE (TYPE H)
TALC
CANDELILLA WAX
WATER
Product Characteristics
ColorWHITEScore2 pieces
ShapeOVALSize18mm
FlavorImprint CodeG;21
Contains
Packaging
#Item CodePackage Description
1NDC:59762-5023-1100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA AUTHORIZED GENERICNDA02088210/09/1998
See also  What are Analgesics and Why Opioids Are the Strongest Pain Killers
Gabapentin 
Gabapentin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:59762-5024
Route of AdministrationORALDEA Schedule
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Gabapentin (Gabapentin)Gabapentin800 mg
Inactive Ingredients
Ingredient NameStrength
POLOXAMER 407
STARCH, CORN
MAGNESIUM STEARATE
HYDROXYPROPYL CELLULOSE (TYPE H)
TALC
CANDELILLA WAX
WATER
Product Characteristics
ColorWHITEScore2 pieces
ShapeOVALSize19mm
FlavorImprint CodeG;22
Contains
Packaging
#Item CodePackage Description
1NDC:59762-5024-1100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA AUTHORIZED GENERICNDA02088210/09/1998
Gabapentin 
Gabapentin suspension
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:59762-5025
Route of AdministrationORALDEA Schedule
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Gabapentin (Gabapentin)Gabapentin250 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN
XYLITOL
WATER
Product Characteristics
ColorScore
ShapeSize
FlavorSTRAWBERRY (cool strawberry anise)Imprint Code
Contains
Packaging
#Item CodePackage Description
1NDC:59762-5025-1470 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA AUTHORIZED GENERICNDA02112903/29/2011
Labeler – Greenstone LLC (825560733)
Registrant – Pfizer Inc (113480771)
Establishment
NameAddressID/FEIOperations
Pfizer Ireland Pharmaceuticals989811526API MANUFACTURE(59762-5023, 59762-5024, 59762-5025, 59762-5026, 59762-5027, 59762-5028)
Establishment
NameAddressID/FEIOperations
Pfizer Asia Pacific PTE LTD894677996API MANUFACTURE(59762-5023, 59762-5024, 59762-5025, 59762-5026, 59762-5027, 59762-5028)
Establishment
NameAddressID/FEIOperations
Pfizer Pharmaceuticals LLC829084552MANUFACTURE(59762-5023, 59762-5024, 59762-5025, 59762-5026, 59762-5027, 59762-5028)
Establishment
NameAddressID/FEIOperations
Hikal Ltd.918602129API MANUFACTURE(59762-5023, 59762-5024, 59762-5025, 59762-5026, 59762-5027, 59762-5028)
See also  Fibromyalgia-Gabapentin- New study about Brain Fog Occurrence
Establishment
NameAddressID/FEIOperations
DPT Laboratories, Ltd.832224526MANUFACTURE(59762-5025, 59762-5024, 59762-5023, 59762-5028, 59762-5027, 59762-5026), PACK(59762-5025, 59762-5024, 59762-5023, 59762-5028, 59762-5027, 59762-5026)
Establishment
NameAddressID/FEIOperations
Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.801375143MANUFACTURE(59762-5025, 59762-5024, 59762-5023, 59762-5028, 59762-5027, 59762-5026), PACK(59762-5025, 59762-5024, 59762-5023, 59762-5028, 59762-5027, 59762-5026)
Establishment
NameAddressID/FEIOperations
Orchid Chemicals & Pharmaceuticals Limited650288850MANUFACTURE(59762-5025, 59762-5024, 59762-5023, 59762-5028, 59762-5027, 59762-5026)
Establishment
NameAddressID/FEIOperations
ZACH SYSTEM SPA517259979API MANUFACTURE(59762-5025, 59762-5024, 59762-5023, 59762-5028, 59762-5027, 59762-5026)
Establishment
NameAddressID/FEIOperations
Pharmacia and Upjohn Company829076566MANUFACTURE(59762-5025, 59762-5024, 59762-5023, 59762-5028, 59762-5027, 59762-5026)
Establishment
NameAddressID/FEIOperations
Emcure Pharmaceuticals Limited862602830MANUFACTURE(59762-5025, 59762-5024, 59762-5023, 59762-5028, 59762-5027, 59762-5026), PACK(59762-5025, 59762-5024, 59762-5023, 59762-5028, 59762-5027, 59762-5026)
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