MedPath
FDA Product

GABAPENTIN

Product approved by U.S. Food and Drug Administration (US)

Basic Information

GABAPENTIN

72189-158

Regulatory Information

72189-158

ANDA203244

C73584

June 28, 2023

USA

GABAPENTIN

HUMAN PRESCRIPTION DRUG LABEL

13

Company Information

DIRECT RX

079254320

Active Ingredients

GABAPENTIN

Quantity: 800 mg in 1 1

Code: 6CW7F3G59X

Class Code: ACTIB

HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Code: 9XZ8H6N6OH

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED

Code: 2165RE0K14

Class Code: IACT

COPOVIDONE K25-31

Code: D9C330MD8B

Class Code: IACT

POLOXAMER 407

Code: TUF2IVW3M2

Class Code: IACT

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYVINYL ALCOHOL, UNSPECIFIED

Code: 532B59J990

Class Code: IACT

Active Moieties

GABAPENTIN

Code: 6CW7F3G59X

© Copyright 2025. All Rights Reserved by MedPath