Glyburide
GLYBURIDE TABLETS, USP Rx only
Approved
Approval ID
e84c0dfc-a4e9-4c89-b6ea-45732eb412f5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 2, 2023
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Glyburide
PRODUCT DETAILS
NDC Product Code0093-8035
Application NumberANDA074686
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 12, 2023
Generic NameGlyburide
INGREDIENTS (8)
GLYBURIDEActive
Quantity: 3 mg in 1 1
Code: SX6K58TVWC
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Glyburide
PRODUCT DETAILS
NDC Product Code0093-8034
Application NumberANDA074686
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 12, 2023
Generic NameGlyburide
INGREDIENTS (6)
GLYBURIDEActive
Quantity: 1.5 mg in 1 1
Code: SX6K58TVWC
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Glyburide
PRODUCT DETAILS
NDC Product Code0093-8036
Application NumberANDA074686
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 12, 2023
Generic NameGlyburide
INGREDIENTS (8)
GLYBURIDEActive
Quantity: 6 mg in 1 1
Code: SX6K58TVWC
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT