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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0440-0605
Application NumberANDA205790
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prasugrel
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2019
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0440-0604
Application NumberANDA205790
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prasugrel
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2019
FDA Product Classification
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