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
93c8deae-3103-4cbf-a5d1-fe0d37e76df8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2024
Manufacturers
FDA
Bayshore Pharmaceuticals LLC
DUNS: 968737416
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 Code76385-129
Application NumberANDA207427
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 19, 2022
FDA Product Classification
INGREDIENTS (6)
METFORMIN HYDROCHLORIDEActive
Quantity: 750 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Metformin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76385-128
Application NumberANDA207427
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 19, 2022
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT