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, COATED
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-381
Product ID 69367-381_982c2026-cf0f-449e-9576-2548af623c35
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205096
Listing Expiration 2026-12-31
Marketing Start 2024-03-04

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69367381
Hyphenated Format 69367-381

Supplemental Identifiers

RxCUI
861004 861007 861010
UPC
0369367381017 0369367382014
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 ANDA205096 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (69367-381-01)
  • 500 TABLET, COATED in 1 BOTTLE (69367-381-05)
  • 1000 TABLET, COATED in 1 BOTTLE (69367-381-10)
source: ndc

Packages (3)

69367-381-01 100 TABLET, COATED in 1 BOTTLE (69367-381-01) 69367-381-05 500 TABLET, COATED in 1 BOTTLE (69367-381-05) 69367-381-10 1000 TABLET, COATED in 1 BOTTLE (69367-381-10)

Ingredients (1)

metformin hydrochloride (500 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": "982c2026-cf0f-449e-9576-2548af623c35", "openfda": {"upc": ["0369367381017", "0369367382014"], "unii": ["786Z46389E"], "rxcui": ["861004", "861007", "861010"], "spl_set_id": ["583dac53-65e7-4710-912a-ecd89d07ad03"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (69367-381-01)", "package_ndc": "69367-381-01", "marketing_start_date": "20240304"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (69367-381-05)", "package_ndc": "69367-381-05", "marketing_start_date": "20240304"}, {"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE (69367-381-10)", "package_ndc": "69367-381-10", "marketing_start_date": "20240304"}], "brand_name": "Metformin Hydrochloride", "product_id": "69367-381_982c2026-cf0f-449e-9576-2548af623c35", "dosage_form": "TABLET, COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "69367-381", "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": "500 mg/1"}], "application_number": "ANDA205096", "marketing_category": "ANDA", "marketing_start_date": "20240304", "listing_expiration_date": "20261231"}