METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE
Approved
Approval ID
495738b9-2511-446b-833c-164c0119035b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2010
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
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 Code21695-471
Application NumberANDA075967
Product Classification
M
Marketing Category
C73584
G
Generic Name
METFORMIN HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 30, 2010
FDA Product Classification
INGREDIENTS (8)
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
METFORMIN HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-472
Application NumberANDA075967
Product Classification
M
Marketing Category
C73584
G
Generic Name
METFORMIN HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 30, 2010
FDA Product Classification
INGREDIENTS (8)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 850 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
METFORMIN HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-473
Application NumberANDA075967
Product Classification
M
Marketing Category
C73584
G
Generic Name
METFORMIN HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 30, 2010
FDA Product Classification
INGREDIENTS (8)
METFORMIN HYDROCHLORIDEActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT