Gabapentin

Basic Information

Product Name

Gabapentin

FDA Product Code

10544-439

Regulatory Information

NDC Product Code

10544-439

Application Number

ANDA077662

Marketing Category

C73584

Effective Date

February 3, 2016

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

COPOVIDONE K25-31

Code: D9C330MD8B

Class Code: IACT

POLOXAMER 407

Code: TUF2IVW3M2

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

GABAPENTIN

Quantity: 600 mg in 1 1

Code: 6CW7F3G59X

Class Code: ACTIB

POLYETHYLENE GLYCOLS

Code: 3WJQ0SDW1A

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

Active Moieties

Code: 6CW7F3G59X

Gabapentin

Basic Information

Regulatory Information

Company Information

Active Ingredients

STARCH, CORN

COPOVIDONE K25-31

POLOXAMER 407

MAGNESIUM STEARATE

TITANIUM DIOXIDE

TALC

WATER

POLYSORBATE 80

POLYETHYLENE GLYCOLS

HYPROMELLOSES

Active Moieties

GABAPENTIN