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, COATED
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer
Coupler, LLC

Identifiers & Regulatory

Product NDC 67046-1554
Product ID 67046-1554_32ff4103-c2ac-d83a-e063-6394a90a97cc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205096
Listing Expiration 2026-12-31
Marketing Start 2025-04-17

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461554
Hyphenated Format 67046-1554

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 ANDA205096 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BLISTER PACK (67046-1554-3)
source: ndc

Packages (1)

67046-1554-3 30 TABLET, COATED in 1 BLISTER PACK (67046-1554-3)

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": "32ff4103-c2ac-d83a-e063-6394a90a97cc", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861004"], "spl_set_id": ["32ff33ed-89ed-c391-e063-6294a90ae414"], "manufacturer_name": ["Coupler, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BLISTER PACK (67046-1554-3)", "package_ndc": "67046-1554-3", "marketing_start_date": "20250417"}], "brand_name": "Metformin Hydrochloride", "product_id": "67046-1554_32ff4103-c2ac-d83a-e063-6394a90a97cc", "dosage_form": "TABLET, COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "67046-1554", "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": "ANDA205096", "marketing_category": "ANDA", "marketing_start_date": "20250417", "listing_expiration_date": "20261231"}