metformin

Generic: metformin

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

Drug Facts

Product Profile

Brand Name metformin
Generic Name metformin
Labeler coupler llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1584
Product ID 67046-1584_3edcaeec-b5bf-2682-e063-6394a90a2ddc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209674
Listing Expiration 2026-12-31
Marketing Start 2025-09-15

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461584
Hyphenated Format 67046-1584

Supplemental Identifiers

RxCUI
1807894
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 (source: ndc)
Generic Name metformin (source: ndc)
Application Number ANDA209674 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1584-3)
source: ndc

Packages (1)

67046-1584-3 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1584-3)

Ingredients (1)

metformin hydrochloride (1000 mg/1)

Linked Drug Pages (1)

Metformin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3edcaeec-b5bf-2682-e063-6394a90a2ddc", "openfda": {"unii": ["786Z46389E"], "rxcui": ["1807894"], "spl_set_id": ["3edc9b51-ddee-61f8-e063-6294a90ad3c5"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1584-3)", "package_ndc": "67046-1584-3", "marketing_start_date": "20250915"}], "brand_name": "Metformin", "product_id": "67046-1584_3edcaeec-b5bf-2682-e063-6394a90a2ddc", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "67046-1584", "generic_name": "metformin", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA209674", "marketing_category": "ANDA", "marketing_start_date": "20250915", "listing_expiration_date": "20261231"}