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Metformin Hydrochloride

Metformin Hydrochloride Tablets, USP

Approved
Approval ID

45cc673a-e125-4d76-8013-89a089eb0ae9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 6, 2012

Manufacturers
FDA

Amneal Pharmaceuticals

DUNS: 123797875

Products 3

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

Metformin

PRODUCT DETAILS

NDC Product Code65162-175
Application NumberANDA077880
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 6, 2012
Generic NameMetformin

INGREDIENTS (1)

METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB

Metformin

PRODUCT DETAILS

NDC Product Code65162-177
Application NumberANDA077880
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 6, 2012
Generic NameMetformin

INGREDIENTS (1)

METFORMIN HYDROCHLORIDEActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB

Metformin

PRODUCT DETAILS

NDC Product Code65162-174
Application NumberANDA077880
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 6, 2012
Generic NameMetformin

INGREDIENTS (1)

METFORMIN HYDROCHLORIDEActive
Quantity: 850 mg in 1 1
Code: 786Z46389E
Classification: ACTIB

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Metformin Hydrochloride - FDA Drug Approval Details