Effient
These highlights do not include all the information needed to use Effient safely and effectively. See full prescribing information for Effient. EFFIENT (prasugrel) tablets Initial U.S. Approval: 2009
Approved
Approval ID
cb684ad9-0b72-406f-8a07-a419254ccd36
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 14, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Prasugrel hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6238
Application NumberNDA022307
Product Classification
M
Marketing Category
C73594
G
Generic Name
Prasugrel hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 16, 2011
FDA Product Classification
INGREDIENTS (11)
PRASUGREL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: G89JQ59I13
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT