metformin hydrochloride

Generic: metformin hydrochloride

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

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler westminster pharmaceuticals, llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-413
Product ID 69367-413_0bcfb466-d20c-472a-8e3e-aee3df526272
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203832
Listing Expiration 2026-12-31
Marketing Start 2025-10-23

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69367413
Hyphenated Format 69367-413

Supplemental Identifiers

RxCUI
1807894 1807917
UPC
0369367412605 0369367413602
UNII
786Z46389E

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 metformin hydrochloride (source: ndc)
Generic Name metformin hydrochloride (source: ndc)
Application Number ANDA203832 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69367-413-60)
source: ndc

Packages (1)

69367-413-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69367-413-60)

Ingredients (1)

metformin hydrochloride (1000 mg/1)

Linked Drug Pages (1)

METFORMIN HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0bcfb466-d20c-472a-8e3e-aee3df526272", "openfda": {"upc": ["0369367412605", "0369367413602"], "unii": ["786Z46389E"], "rxcui": ["1807894", "1807917"], "spl_set_id": ["07b4ee2a-8435-4d38-a6b0-b919e3424153"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69367-413-60)", "package_ndc": "69367-413-60", "marketing_start_date": "20251023"}], "brand_name": "METFORMIN HYDROCHLORIDE", "product_id": "69367-413_0bcfb466-d20c-472a-8e3e-aee3df526272", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "69367-413", "generic_name": "METFORMIN HYDROCHLORIDE", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA203832", "marketing_category": "ANDA", "marketing_start_date": "20251023", "listing_expiration_date": "20261231"}