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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-175
Application NumberANDA077880
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 6, 2012
FDA Product Classification
INGREDIENTS (1)
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
Metformin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-177
Application NumberANDA077880
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 6, 2012
FDA Product Classification
INGREDIENTS (1)
METFORMIN HYDROCHLORIDEActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
Metformin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-174
Application NumberANDA077880
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 6, 2012
FDA Product Classification
INGREDIENTS (1)
METFORMIN HYDROCHLORIDEActive
Quantity: 850 mg in 1 1
Code: 786Z46389E
Classification: ACTIB