metformin hcl

Generic: metformin hcl

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hcl
Generic Name metformin hcl
Labeler advanced rx of tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0435
Product ID 80425-0435_22cef642-e37b-a74f-e063-6394a90aef9d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090564
Listing Expiration 2026-12-31
Marketing Start 2024-09-03

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250435
Hyphenated Format 80425-0435

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 hcl (source: ndc)
Generic Name metformin hcl (source: ndc)
Application Number ANDA090564 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (80425-0435-1)
  • 60 TABLET in 1 BOTTLE (80425-0435-2)
  • 90 TABLET in 1 BOTTLE (80425-0435-3)
  • 108 TABLET in 1 BOTTLE (80425-0435-4)
source: ndc

Packages (4)

80425-0435-1 30 TABLET in 1 BOTTLE (80425-0435-1) 80425-0435-2 60 TABLET in 1 BOTTLE (80425-0435-2) 80425-0435-3 90 TABLET in 1 BOTTLE (80425-0435-3) 80425-0435-4 108 TABLET in 1 BOTTLE (80425-0435-4)

Ingredients (1)

metformin hydrochloride (1000 mg/1)

Linked Drug Pages (1)

Metformin HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "22cef642-e37b-a74f-e063-6394a90aef9d", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861004"], "spl_set_id": ["21b76183-af30-e06f-e063-6394a90a9653"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (80425-0435-1)", "package_ndc": "80425-0435-1", "marketing_start_date": "20240903"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (80425-0435-2)", "package_ndc": "80425-0435-2", "marketing_start_date": "20240903"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (80425-0435-3)", "package_ndc": "80425-0435-3", "marketing_start_date": "20240903"}, {"sample": false, "description": "108 TABLET in 1 BOTTLE (80425-0435-4)", "package_ndc": "80425-0435-4", "marketing_start_date": "20240903"}], "brand_name": "Metformin HCl", "product_id": "80425-0435_22cef642-e37b-a74f-e063-6394a90aef9d", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "80425-0435", "generic_name": "Metformin HCl", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin HCl", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA090564", "marketing_category": "ANDA", "marketing_start_date": "20240903", "listing_expiration_date": "20261231"}