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 useInitial U.S. Approval: 2009
Approved
Approval ID
60853d14-ac2a-4e48-9c0c-afd8069b83c6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2019
Manufacturers
FDA
Liberty Pharmaceuticals, Inc.
DUNS: 012568840
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Prasugrel
PRODUCT DETAILS
NDC Product Code0440-0605
Application NumberANDA205790
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 1, 2019
Generic NamePrasugrel
INGREDIENTS (12)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
PRASUGREL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: G89JQ59I13
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SR
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
Prasugrel
PRODUCT DETAILS
NDC Product Code0440-0604
Application NumberANDA205790
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 1, 2019
Generic NamePrasugrel
INGREDIENTS (12)
PRASUGREL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: G89JQ59I13
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
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
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SR
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT