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FDA Drug information

Gabapentin

Read time: 1 mins
Marketing start date: 12 Jan 2025
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Summary of product characteristics


Effective Time

20241130

Version

2

Spl Product Data Elements

gabapentin gabapentin GABAPENTIN GABAPENTIN CELLULOSE, MICROCRYSTALLINE COPOVIDONE K25-31 HYPROMELLOSE 2208 (100000 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MAGNESIUM STEARATE POLYETHYLENE GLYCOL 6000 POLYETHYLENE GLYCOL 7000000 POVIDONE K90 TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE 608 gabapentin gabapentin GABAPENTIN GABAPENTIN CELLULOSE, MICROCRYSTALLINE COPOVIDONE K25-31 HYPROMELLOSE 2208 (100000 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MAGNESIUM STEARATE POLYETHYLENE GLYCOL 6000 POLYETHYLENE GLYCOL 7000000 POVIDONE K90 TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE 607

Application Number

ANDA203934

Brand Name

Gabapentin

Generic Name

gabapentin

Product Ndc

70771-1861

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1861-9 in bottle of 90 tablets Gabapentin tablets, 300 mg Rx only 90 tablets gabapentin 300 mg NDC 70771-1862-9 in bottle of 90 tablets Gabapentin tablets, 600 mg Rx only 90 tablets gabapentin 600 mg gabapentin 300 mg gabapentin 600 mg

Spl Unclassified Section

SPL UNCLASSIFIED

Spl Medguide

SPL MEDGUIDE

Drug section

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