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 TABLET, COATED
Routes
ORAL
Active Ingredients

gabapentin 600 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-346
Product ID 69367-346_3855844f-e123-4574-8d9b-76397d602744
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207057
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 69367346
Hyphenated Format 69367-346

Supplemental Identifiers

RxCUI
310433 310434
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 ANDA207057 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 500 TABLET, COATED in 1 BOTTLE, PLASTIC (69367-346-05)
source: ndc

Packages (1)

69367-346-05 500 TABLET, COATED in 1 BOTTLE, PLASTIC (69367-346-05)

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": "3855844f-e123-4574-8d9b-76397d602744", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310433", "310434"], "spl_set_id": ["2eec52a1-9016-46dd-8b4c-8dab1d0aeece"], "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 TABLET, COATED in 1 BOTTLE, PLASTIC (69367-346-05)", "package_ndc": "69367-346-05", "marketing_start_date": "20211101"}], "brand_name": "Gabapentin", "product_id": "69367-346_3855844f-e123-4574-8d9b-76397d602744", "dosage_form": "TABLET, COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "69367-346", "generic_name": "Gabapentin", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "600 mg/1"}], "application_number": "ANDA207057", "marketing_category": "ANDA", "marketing_start_date": "20211101", "listing_expiration_date": "20261231"}