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, FILM COATED
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1594
Product ID 67046-1594_3eeee505-7359-01ee-e063-6294a90ae5e3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209882
Listing Expiration 2026-12-31
Marketing Start 2025-09-16

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461594
Hyphenated Format 67046-1594

Supplemental Identifiers

RxCUI
861007
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 ANDA209882 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1594-3)
source: ndc

Packages (1)

67046-1594-3 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1594-3)

Ingredients (1)

metformin hydrochloride (500 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": "3eeee505-7359-01ee-e063-6294a90ae5e3", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861007"], "spl_set_id": ["3eeee3b7-188a-05a0-e063-6294a90a1853"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1594-3)", "package_ndc": "67046-1594-3", "marketing_start_date": "20250916"}], "brand_name": "Metformin Hydrochloride", "product_id": "67046-1594_3eeee505-7359-01ee-e063-6294a90ae5e3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "67046-1594", "generic_name": "Metformin Hydrochloride", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA209882", "marketing_category": "ANDA", "marketing_start_date": "20250916", "listing_expiration_date": "20261231"}