Glyburide
for oral use These highlights do not include all the information needed to use Glyburide safely and effectively. See full prescribing information for Glyburide Glyburide (Glyburide) TABLET for ORAL use. Initial U.S. Approval:
Approved
Approval ID
901c513c-9e35-b06c-e053-2995a90adfcc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 19, 2021
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Glyburide
PRODUCT DETAILS
NDC Product Code68071-5029
Application NumberANDA090937
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateFebruary 19, 2021
Generic NameGlyburide
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GLYBURIDEActive
Quantity: 2.5 mg in 1 1
Code: SX6K58TVWC
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT