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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68071-2402
Application NumberANDA206483
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glyburide
Product Specifications
Route of AdministrationORAL
Effective DateMay 13, 2021
FDA Product Classification
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