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 useInitial U.S. Approval: 1995
Approved
Approval ID
85027e6c-d35b-49eb-a234-dd71aa77aee0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2023
Manufacturers
FDA
Viona Pharmaceuticals Inc
DUNS: 081468959
Products 2
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 Code72578-035
Application NumberANDA077060
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (5)
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SR
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
Metformin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72578-036
Application NumberANDA077078
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (5)
METFORMIN HYDROCHLORIDEActive
Quantity: 750 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SR
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT