Glimepiride
These highlights do not include all the information needed to use GLIMEPIRIDE TABLETS safely and effectively. See full prescribing information for GLIMEPIRIDE TABLETS.GLIMEPIRIDE tablets, for oral useInitial U.S. Approval: 1995
Approved
Approval ID
4419ca50-539c-47e8-ab00-dbb45c7c1814
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 22, 2019
Manufacturers
FDA
Virtus Pharmaceuticals
DUNS: 079659493
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Glimepiride
PRODUCT DETAILS
NDC Product Code69543-125
Application NumberANDA202112
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 30, 2018
Generic NameGlimepiride
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GLIMEPIRIDEActive
Quantity: 4 mg in 1 1
Code: 6KY687524K
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Glimepiride
PRODUCT DETAILS
NDC Product Code69543-124
Application NumberANDA202112
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 30, 2018
Generic NameGlimepiride
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
GLIMEPIRIDEActive
Quantity: 2 mg in 1 1
Code: 6KY687524K
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Glimepiride
PRODUCT DETAILS
NDC Product Code69543-123
Application NumberANDA202112
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 30, 2018
Generic NameGlimepiride
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
GLIMEPIRIDEActive
Quantity: 1 mg in 1 1
Code: 6KY687524K
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT