gabapentin

Generic: gabapentin

Labeler: westminster pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler westminster pharmaceuticals, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

gabapentin 400 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-345
Product ID 69367-345_e369733c-4898-4f60-9499-db7c27a2f3c1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075477
Listing Expiration 2026-12-31
Marketing Start 2021-11-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69367345
Hyphenated Format 69367-345

Supplemental Identifiers

RxCUI
310430 310431 310432
UPC
0369367344050 0369367343053
UNII
6CW7F3G59X
NUI
N0000008486

Packaging Origin

Original Packager
true

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 ANDA075477 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 500 CAPSULE in 1 BOTTLE, PLASTIC (69367-345-05)
source: ndc

Packages (1)

69367-345-05 500 CAPSULE in 1 BOTTLE, PLASTIC (69367-345-05)

Ingredients (1)

gabapentin (400 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": "e369733c-4898-4f60-9499-db7c27a2f3c1", "openfda": {"nui": ["N0000008486"], "upc": ["0369367344050", "0369367343053"], "unii": ["6CW7F3G59X"], "rxcui": ["310430", "310431", "310432"], "spl_set_id": ["3ad96553-73a4-4a9b-8a89-10a29b794ed3"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE in 1 BOTTLE, PLASTIC (69367-345-05)", "package_ndc": "69367-345-05", "marketing_start_date": "20211101"}], "brand_name": "Gabapentin", "product_id": "69367-345_e369733c-4898-4f60-9499-db7c27a2f3c1", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "69367-345", "generic_name": "Gabapentin", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "400 mg/1"}], "application_number": "ANDA075477", "marketing_category": "ANDA", "marketing_start_date": "20211101", "listing_expiration_date": "20261231"}