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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-8035
Application NumberANDA074686
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glyburide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-8034
Application NumberANDA074686
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glyburide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-8036
Application NumberANDA074686
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glyburide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2023
FDA Product Classification
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