metformin hydrochloride

Generic: metformin hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-941
Product ID 71610-941_3d451d25-9aba-a066-e063-6394a90a86b7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077095
Listing Expiration 2026-12-31
Marketing Start 2024-03-29

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610941
Hyphenated Format 71610-941

Supplemental Identifiers

RxCUI
861004
UNII
786Z46389E

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 ANDA077095 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-941-60)
  • 180 TABLET, FILM COATED in 1 BOTTLE (71610-941-80)
source: ndc

Packages (2)

71610-941-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-941-60) 71610-941-80 180 TABLET, FILM COATED in 1 BOTTLE (71610-941-80)

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": "3d451d25-9aba-a066-e063-6394a90a86b7", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861004"], "spl_set_id": ["3d450933-8d9d-27de-e063-6294a90ae6d9"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-941-60)", "package_ndc": "71610-941-60", "marketing_start_date": "20250825"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (71610-941-80)", "package_ndc": "71610-941-80", "marketing_start_date": "20250825"}], "brand_name": "Metformin Hydrochloride", "product_id": "71610-941_3d451d25-9aba-a066-e063-6394a90a86b7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "71610-941", "generic_name": "Metformin Hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA077095", "marketing_category": "ANDA", "marketing_start_date": "20240329", "listing_expiration_date": "20261231"}