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
de7049ae-d1d6-4267-a93b-dd5039c50c2c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2021
Manufacturers
FDA
Teva Pharmaceuticals, Inc.
DUNS: 022629579
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 Code0480-0127
Application NumberANDA209525
Product Classification
M
Marketing Category
C73584
G
Generic Name
Icosapent Ethyl
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2021
FDA Product Classification
INGREDIENTS (10)
ICOSAPENT ETHYLActive
Quantity: 1 g in 1 1
Code: 6GC8A4PAYH
Classification: ACTIB
ETHYL ACETATEInactive
Code: 76845O8NMZ
Classification: IACT
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
Polyvinyl Acetate PhthalateInactive
Code: 58QVG85GW3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
Icosapent Ethyl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0480-0126
Application NumberANDA209525
Product Classification
M
Marketing Category
C73584
G
Generic Name
Icosapent Ethyl
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2021
FDA Product Classification
INGREDIENTS (10)
ICOSAPENT ETHYLActive
Quantity: 500 mg in 1 1
Code: 6GC8A4PAYH
Classification: ACTIB
ETHYL ACETATEInactive
Code: 76845O8NMZ
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
Polyvinyl Acetate PhthalateInactive
Code: 58QVG85GW3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT