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.

NDC Product Code71335-0069

Application NumberANDA090937

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateApril 2, 2021

Generic NameGLYBURIDE

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