MedPath

Gabapentin

Gabapentin Capsules

Approved
Approval ID

591e0212-71ac-4f7a-b30a-8f4b745b263b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 27, 2011

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Gabapentin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42254-103
Application NumberANDA078428
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2009
FDA Product Classification

INGREDIENTS (1)

GABAPENTINActive
Quantity: 100 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB

Gabapentin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42254-112
Application NumberANDA078428
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2009
FDA Product Classification

INGREDIENTS (1)

GABAPENTINActive
Quantity: 400 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Gabapentin - FDA Drug Approval Details