Icosapent
ICOSAPENT ETHYL capsules, for oral use 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. Initial U.S. Approval: 2012
Approved
Approval ID
0fb2eb8a-e308-0177-e063-6294a90a7418
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2024
Manufacturers
FDA
AvKARE
DUNS: 796560394
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 Code42291-032
Application NumberANDA209499
Product Classification
M
Marketing Category
C73584
G
Generic Name
Icosapent Ethyl
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 24, 2024
FDA Product Classification
INGREDIENTS (12)
TOCOPHEROLInactive
Quantity: 2 mg in 1 1
Code: R0ZB2556P8
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYVINYL ACETATE PHTHALATEInactive
Code: 58QVG85GW3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ICOSAPENT ETHYLActive
Quantity: 1000 mg in 1 1
Code: 6GC8A4PAYH
Classification: ACTIB