GLIMEPIRIDE
Approved
Approval ID
1873bce1-172f-4eb0-b5bc-cb7d444a8d8e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2018
Manufacturers
FDA
International Laboratories, LLC
DUNS: 023569924
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
GLIMEPIRIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54458-968
Application NumberANDA077091
Product Classification
M
Marketing Category
C73584
G
Generic Name
GLIMEPIRIDE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 26, 2019
FDA Product Classification
INGREDIENTS (7)
GLIMEPIRIDEActive
Quantity: 1 mg in 1 1
Code: 6KY687524K
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GLIMEPIRIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54458-967
Application NumberANDA077091
Product Classification
M
Marketing Category
C73584
G
Generic Name
GLIMEPIRIDE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 26, 2019
FDA Product Classification
INGREDIENTS (8)
GLIMEPIRIDEActive
Quantity: 2 mg in 1 1
Code: 6KY687524K
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
GLIMEPIRIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54458-966
Application NumberANDA077091
Product Classification
M
Marketing Category
C73584
G
Generic Name
GLIMEPIRIDE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 26, 2019
FDA Product Classification
INGREDIENTS (8)
GLIMEPIRIDEActive
Quantity: 4 mg in 1 1
Code: 6KY687524K
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT