gabapentin

Generic: gabapentin

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

gabapentin 600 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8491
Product ID 63629-8491_77d1ac6f-12ec-4a4d-99ea-e6e26f7ef1af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205101
Listing Expiration 2026-12-31
Marketing Start 2016-02-04

Pharmacologic Class

Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636298491
Hyphenated Format 63629-8491

Supplemental Identifiers

RxCUI
310433
UNII
6CW7F3G59X
NUI
N0000008486

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name gabapentin (source: ndc)
Generic Name gabapentin (source: ndc)
Application Number ANDA205101 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (63629-8491-1)
source: ndc

Packages (1)

63629-8491-1 500 TABLET in 1 BOTTLE (63629-8491-1)

Ingredients (1)

gabapentin (600 mg/1)

Linked Drug Pages (1)

Gabapentin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "77d1ac6f-12ec-4a4d-99ea-e6e26f7ef1af", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310433"], "spl_set_id": ["abb56036-88df-4720-ba78-529971671545"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (63629-8491-1)", "package_ndc": "63629-8491-1", "marketing_start_date": "20160204"}], "brand_name": "Gabapentin", "product_id": "63629-8491_77d1ac6f-12ec-4a4d-99ea-e6e26f7ef1af", "dosage_form": "TABLET", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "63629-8491", "generic_name": "Gabapentin", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "600 mg/1"}], "application_number": "ANDA205101", "marketing_category": "ANDA", "marketing_start_date": "20160204", "listing_expiration_date": "20261231"}