MedPath

GABAPENTIN

gabapentin 300mg

Approved
Approval ID

570b880f-f519-22b3-e054-00144ff8d46c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 21, 2022

Manufacturers
FDA

RedPharm Drug, Inc.

DUNS: 828374897

Products 1

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 Code67296-1536
Application NumberANDA090705
Product Classification
M
Marketing Category
C73584
G
Generic Name
GABAPENTIN
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2022
FDA Product Classification

INGREDIENTS (5)

GABAPENTINActive
Quantity: 300 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

GABAPENTIN - FDA Drug Approval Details