METFORMIN HYDROCHLORIDE
These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
Approved
Approval ID
33ec9f6e-16d9-40ba-e063-6294a90ae87b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 29, 2025
Manufacturers
FDA
Coupler LLC
DUNS: 119003108
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
METFORMIN HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-1556
Application NumberANDA217631
Product Classification
M
Marketing Category
C73584
G
Generic Name
METFORMIN HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateApril 29, 2025
FDA Product Classification
INGREDIENTS (4)
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
HYPROMELLOSE 2208 (100000 MPA.S)Inactive
Code: VM7F0B23ZI
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 750 mg in 1 1
Code: 786Z46389E
Classification: ACTIB