Glimepiride
GLIMEPIRIDE TABLETS USP 725472557256Rx only
Approved
Approval ID
c68bb847-5d17-4d63-99d4-e72f92a31392
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 24, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-3377
Application NumberANDA076802
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glimepiride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 11, 2011
FDA Product Classification
INGREDIENTS (8)
GLIMEPIRIDEActive
Quantity: 4 mg in 1 1
Code: 6KY687524K
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
Glimepiride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3327
Application NumberANDA076802
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glimepiride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 11, 2011
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GLIMEPIRIDEActive
Quantity: 1 mg in 1 1
Code: 6KY687524K
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Glimepiride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5457
Application NumberANDA076802
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glimepiride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 11, 2011
FDA Product Classification
INGREDIENTS (9)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
GLIMEPIRIDEActive
Quantity: 2 mg in 1 1
Code: 6KY687524K
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT