GLYBURIDE
Glyburide Tablets, USP1.25, 2.5, and 5 mg
Approved
Approval ID
9cdd30e7-512a-4f00-a4de-0a154d143ce9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
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 Code71335-0069
Application NumberANDA090937
Product Classification
M
Marketing Category
C73584
G
Generic Name
GLYBURIDE
Product Specifications
Route of AdministrationORAL
Effective DateApril 2, 2021
FDA Product Classification
INGREDIENTS (5)
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GLYBURIDEActive
Quantity: 2.5 mg in 1 1
Code: SX6K58TVWC
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT