Glyburide
Glyburide Tablets, USP 1.25 mg, 2.5 mg and 5 mg For Oral Use
Approved
Approval ID
04201349-2a01-4fc1-9920-1ef7376d352f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2014
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Glyburide
PRODUCT DETAILS
NDC Product Code33261-209
Application NumberANDA090937
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 4, 2014
Generic NameGlyburide
INGREDIENTS (5)
GLYBURIDEActive
Quantity: 5 mg in 1 1
Code: SX6K58TVWC
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Glyburide
PRODUCT DETAILS
NDC Product Code33261-813
Application NumberANDA090937
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 4, 2014
Generic NameGlyburide
INGREDIENTS (5)
GLYBURIDEActive
Quantity: 2.5 mg in 1 1
Code: SX6K58TVWC
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT