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
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-182
Product ID 69367-182_fef0f898-a921-462b-9625-626d0e52d8f5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203769
Listing Expiration 2026-12-31
Marketing Start 2017-11-21

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69367182
Hyphenated Format 69367-182

Supplemental Identifiers

RxCUI
861004 861007 861010
UPC
0369367180016 0369367181013 0369367182010
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 ANDA203769 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-182-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-182-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-182-10)
source: ndc

Packages (3)

69367-182-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-182-01) 69367-182-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-182-05) 69367-182-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-182-10)

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": "fef0f898-a921-462b-9625-626d0e52d8f5", "openfda": {"upc": ["0369367180016", "0369367181013", "0369367182010"], "unii": ["786Z46389E"], "rxcui": ["861004", "861007", "861010"], "spl_set_id": ["836f3647-bfef-40d1-b475-c0d240241a67"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-182-01)", "package_ndc": "69367-182-01", "marketing_start_date": "20171121"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-182-05)", "package_ndc": "69367-182-05", "marketing_start_date": "20171121"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-182-10)", "package_ndc": "69367-182-10", "marketing_start_date": "20200421"}], "brand_name": "Metformin Hydrochloride", "product_id": "69367-182_fef0f898-a921-462b-9625-626d0e52d8f5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "69367-182", "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": "ANDA203769", "marketing_category": "ANDA", "marketing_start_date": "20171121", "listing_expiration_date": "20261231"}