Glyburide
GLYBURIDE TABLETS USP Rx only
Approved
Approval ID
c23cfac8-bfa5-95f4-e053-2a95a90aab0f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 13, 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 Code68071-2402
Application NumberANDA206483
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 13, 2021
Generic NameGlyburide
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
GLYBURIDEActive
Quantity: 5 mg in 1 1
Code: SX6K58TVWC
Classification: ACTIB