Glyburide
GLYBURIDE TABLETS USP Rx only
Approved
Approval ID
3152f552-f0ac-4603-8110-3112e4d053b2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 26, 2019
Manufacturers
FDA
Orient Pharma Co., Ltd.
DUNS: 658849810
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 Code76333-154
Application NumberANDA206483
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glyburide
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 26, 2019
FDA Product Classification
INGREDIENTS (6)
GLYBURIDEActive
Quantity: 1.25 mg in 1 1
Code: SX6K58TVWC
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Glyburide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76333-156
Application NumberANDA206483
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glyburide
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 26, 2019
FDA Product Classification
INGREDIENTS (5)
GLYBURIDEActive
Quantity: 5 mg in 1 1
Code: SX6K58TVWC
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Glyburide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76333-155
Application NumberANDA206483
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glyburide
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 26, 2019
FDA Product Classification
INGREDIENTS (6)
GLYBURIDEActive
Quantity: 2.5 mg in 1 1
Code: SX6K58TVWC
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT