Icosapent Ethyl
These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral useInitial U.S. Approval: 2012
Approved
Approval ID
f9c1a6a6-cda4-49ea-97e9-0d3cf5ab5d4c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 15, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Icosapent Ethyl
PRODUCT DETAILS
NDC Product Code63629-9311
Application NumberANDA209457
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 4, 2020
Generic NameIcosapent Ethyl
INGREDIENTS (14)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
ICOSAPENT ETHYLActive
Quantity: 1 g in 1 1
Code: 6GC8A4PAYH
Classification: ACTIB
.ALPHA.-TOCOPHEROLInactive
Quantity: 2 mg in 1 1
Code: H4N855PNZ1
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
POLYVINYL ACETATE PHTHALATEInactive
Code: 58QVG85GW3
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ETHYL ACETATEInactive
Code: 76845O8NMZ
Classification: IACT
SORBITANInactive
Code: 6O92ICV9RU
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT