Prasugrel
These highlights do not include all the information needed to use PRASUGREL TABLETS safely and effectively. See full prescribing information for PRASUGREL TABLETS. PRASUGREL tablets, for oral use Initial U.S. Approval: 2009
Approved
Approval ID
f51e64e0-f556-65d0-a876-fb709aaeefea
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 9, 2020
Manufacturers
FDA
Apotex Corp.
DUNS: 845263701
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PRASUGREL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-4856
Application NumberANDA205897
Product Classification
M
Marketing Category
C73584
G
Generic Name
PRASUGREL
Product Specifications
Route of AdministrationORAL
Effective DateMarch 3, 2025
FDA Product Classification
INGREDIENTS (12)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SR
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
PRASUGREL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: G89JQ59I13
Classification: ACTIM
Prasugrel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-4643
Application NumberANDA205897
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prasugrel
Product Specifications
Route of AdministrationORAL
Effective DateDecember 9, 2020
FDA Product Classification
INGREDIENTS (15)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
Prasugrel HydrochlorideActive
Quantity: 10 mg in 1 1
Code: G89JQ59I13
Classification: ACTIM
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SR
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
PRASUGREL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: G89JQ59I13
Classification: ACTIM
Prasugrel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-4642
Application NumberANDA205897
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prasugrel
Product Specifications
Route of AdministrationORAL
Effective DateDecember 9, 2020
FDA Product Classification
INGREDIENTS (14)
Prasugrel HydrochlorideActive
Quantity: 5 mg in 1 1
Code: G89JQ59I13
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SR
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PRASUGREL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: G89JQ59I13
Classification: ACTIM