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
944c195a-de24-a44c-8baa-84b624b5ddcb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 9, 2020
Manufacturers
FDA
Panacea Biotec Limited
DUNS: 650090566
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 Code43817-239
Application NumberANDA205897
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 12, 2020
Generic NamePrasugrel
INGREDIENTS (11)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
Prasugrel HydrochlorideActive
Quantity: 5 mg in 1 1
Code: G89JQ59I13
Classification: ACTIM
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SR
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Prasugrel
PRODUCT DETAILS
NDC Product Code43817-240
Application NumberANDA205897
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 12, 2020
Generic NamePrasugrel
INGREDIENTS (12)
Prasugrel HydrochlorideActive
Quantity: 10 mg in 1 1
Code: G89JQ59I13
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SR
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT