metformin hydrochloride

Generic: metformin hydrochloride

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1516
Product ID 67046-1516_2d7d92eb-4d87-f72b-e063-6294a90ac932
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213320
Listing Expiration 2026-12-31
Marketing Start 2025-02-06

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461516
Hyphenated Format 67046-1516

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 ANDA213320 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1516-3)
source: ndc

Packages (1)

67046-1516-3 30 TABLET in 1 BLISTER PACK (67046-1516-3)

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": "2d7d92eb-4d87-f72b-e063-6294a90ac932", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861004"], "spl_set_id": ["2d7d9364-e71d-4ef6-e063-6394a90af841"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1516-3)", "package_ndc": "67046-1516-3", "marketing_start_date": "20250206"}], "brand_name": "METFORMIN HYDROCHLORIDE", "product_id": "67046-1516_2d7d92eb-4d87-f72b-e063-6294a90ac932", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "67046-1516", "generic_name": "metformin hydrochloride", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA213320", "marketing_category": "ANDA", "marketing_start_date": "20250206", "listing_expiration_date": "20261231"}