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Metformin Hydrochloride

Metformin Hydrochloride Extended-Release Tablets, USP

Approved
Approval ID

737e5f81-3d75-2eb6-e053-2991aa0a5c69

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 19, 2021

Manufacturers
FDA

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

DUNS: 080355546

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 Code70934-117
Application NumberANDA078321
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2021
FDA Product Classification

INGREDIENTS (6)

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 750 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

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Metformin Hydrochloride - FDA Drug Approval Details