FDA Product

GABAPENTIN

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

Basic Information

Product Name

GABAPENTIN

FDA Product Code

61919-563

Regulatory Information

NDC Product Code

61919-563

Application Number

ANDA202764

Marketing Category

C73584

Effective Date

November 18, 2016

Territorial Authority

USA

FDA Title

GABAPENTIN

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

4

Company Information

ManufacturerDIRECT RX

DUNS Number

079254320

Active Ingredients

TALC

Code: 7SEV7J4R1U

Class Code: IACT

Quantity: 600 mg in 1 1

Code: 6CW7F3G59X

Class Code: ACTIB

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYETHYLENE GLYCOLS

Code: 3WJQ0SDW1A

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

HYDROXYPROPYL CELLULOSE (TYPE H)

Code: RFW2ET671P

Class Code: IACT

Active Moieties

GABAPENTIN

Code: 6CW7F3G59X

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