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 use Initial U.S. Approval: 2012
Approved
Approval ID
5910742b-c5e6-4029-9a19-97669e3808bc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 1, 2023
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
Products 2
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 Code70710-1738
Application NumberANDA217656
Product Classification
M
Marketing Category
C73584
G
Generic Name
icosapent ethyl
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2023
FDA Product Classification
INGREDIENTS (7)
ICOSAPENT ETHYLActive
Quantity: 0.5 g in 1 1
Code: 6GC8A4PAYH
Classification: ACTIB
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
icosapent ethyl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70710-1592
Application NumberANDA217656
Product Classification
M
Marketing Category
C73584
G
Generic Name
icosapent ethyl
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2023
FDA Product Classification
INGREDIENTS (7)
ICOSAPENT ETHYLActive
Quantity: 1 g in 1 1
Code: 6GC8A4PAYH
Classification: ACTIB
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT