metformin hydrochloride

Generic: metformin hydrochloride

Labeler: metcure pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler metcure pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer
Metcure Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 71709-112
Product ID 71709-112_63699815-ee85-645d-e053-2a91aa0a7c4f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090564
Listing Expiration 2026-12-31
Marketing Start 2017-11-14

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71709112
Hyphenated Format 71709-112

Supplemental Identifiers

RxCUI
861004 861007 861010
UPC
0371709110063 0371709111060
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 ANDA090564 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (71709-112-06)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (71709-112-07)
source: ndc

Packages (2)

71709-112-06 500 TABLET, FILM COATED in 1 BOTTLE (71709-112-06) 71709-112-07 1000 TABLET, FILM COATED in 1 BOTTLE (71709-112-07)

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": "63699815-ee85-645d-e053-2a91aa0a7c4f", "openfda": {"upc": ["0371709110063", "0371709111060"], "unii": ["786Z46389E"], "rxcui": ["861004", "861007", "861010"], "spl_set_id": ["5df6adc9-79fd-66ef-e053-2991aa0a75ce"], "manufacturer_name": ["Metcure Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (71709-112-06)", "package_ndc": "71709-112-06", "marketing_start_date": "20171114"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (71709-112-07)", "package_ndc": "71709-112-07", "marketing_start_date": "20171114"}], "brand_name": "Metformin Hydrochloride", "product_id": "71709-112_63699815-ee85-645d-e053-2a91aa0a7c4f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "71709-112", "generic_name": "Metformin Hydrochloride", "labeler_name": "Metcure Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA090564", "marketing_category": "ANDA", "marketing_start_date": "20171114", "listing_expiration_date": "20261231"}