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
45f8bb41-bdb1-4afc-83ec-9dc69720ee9c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2023
Manufacturers
FDA
Northstar Rx LLC
DUNS: 830546433
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72603-129
Application NumberANDA209457
Product Classification
M
Marketing Category
C73584
G
Generic Name
Icosapent Ethyl
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2022
FDA Product Classification
INGREDIENTS (14)
ICOSAPENT ETHYLActive
Quantity: 1 g in 1 1
Code: 6GC8A4PAYH
Classification: ACTIB
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Quantity: 2 mg in 1 1
Code: H4N855PNZ1
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
ETHYL ACETATEInactive
Code: 76845O8NMZ
Classification: IACT
SORBITANInactive
Code: 6O92ICV9RU
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYVINYL ACETATE PHTHALATEInactive
Code: 58QVG85GW3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT