Metformin Hydrochloride
Metformin Hydrochloride Tablets USP
Approved
Approval ID
a488f7cb-10b4-43e2-a468-e032c5ca0de1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 9, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 3
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 Code53808-0381
Application NumberANDA078170
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 9, 2010
FDA Product Classification
INGREDIENTS (7)
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Metformin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0712
Application NumberANDA078170
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 9, 2010
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
Metformin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0717
Application NumberANDA078170
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 9, 2010
FDA Product Classification
INGREDIENTS (7)
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 850 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT