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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33261-209
Application NumberANDA090937
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glyburide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2014
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33261-813
Application NumberANDA090937
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glyburide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2014
FDA Product Classification
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