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
d01b63e6-70e5-4679-b377-1e0fb78a87b5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 16, 2020
Manufacturers
FDA
Nivagen Pharmaceuticals Inc
DUNS: 052032418
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 Code75834-500
Application NumberANDA201991
Product Classification
M
Marketing Category
C73584
G
Generic Name
metformin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 16, 2020
FDA Product Classification
INGREDIENTS (4)
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB