Gabapentin

Basic Information

Product Name

Gabapentin

FDA Product Code

68788-7757

Regulatory Information

NDC Product Code

68788-7757

Application Number

ANDA205101

Marketing Category

C73584

Effective Date

June 29, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

POLOXAMER 407

Code: TUF2IVW3M2

Class Code: IACT

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

GABAPENTIN

Quantity: 800 mg in 1 1

Code: 6CW7F3G59X

Class Code: ACTIB

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CROSPOVIDONE

Code: 2S7830E561

Class Code: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Code: 9XZ8H6N6OH

Class Code: IACT

COPOVIDONE K25-31

Code: D9C330MD8B

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

Code: 6CW7F3G59X

Gabapentin

Basic Information

Regulatory Information

Company Information

Active Ingredients

POLOXAMER 407

MANNITOL

MAGNESIUM STEARATE

CROSPOVIDONE

HYDROXYPROPYL CELLULOSE, UNSPECIFIED

COPOVIDONE K25-31

TALC

SILICON DIOXIDE

POLYETHYLENE GLYCOL, UNSPECIFIED

HYPROMELLOSE, UNSPECIFIED

TITANIUM DIOXIDE

Active Moieties

GABAPENTIN