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Metformin ER 500 mg

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

b857eccf-b9ff-45ba-8241-f47f5caada2a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 27, 2023

Manufacturers
FDA

Granules India Ltd

DUNS: 915000087

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Metformin ER 750 mg

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62207-492
Application NumberANDA209313
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin ER 750 mg
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 27, 2023
FDA Product Classification

INGREDIENTS (4)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 750 mg in 1 1
Code: 786Z46389E
Classification: ACTIB

Metformin ER 500 mg

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62207-491
Application NumberANDA209313
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin ER 500 mg
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 27, 2023
FDA Product Classification

INGREDIENTS (4)

HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB

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Metformin ER 500 mg - FDA Drug Approval Details