FDA.reportPublic FDA data

icosapent ethyl 0.5 GM Oral Capsule

RxCUI
1811180
RxNorm name
icosapent ethyl 0.5 GM Oral Capsule
Display name
icosapent ethyl 0.5 GM Oral Capsule
Full name
icosapent ethyl 0.5 GM Oral Capsule
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:10

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Icosapent EthylICOSAPENT ETHYLDr. Reddy's Laboratories, Inc.cdcee03e-5df1-a8fc-7490-dfdc624ce6d62026-07-22Warnings, Adverse reactionsExact identifier
rxcui: 1811180
Icosapent EthylICOSAPENT ETHYLHikma Pharmaceuticals USA Inc.e3d38d1d-fbe7-413d-849a-675e7dfa9b0a2026-07-09Warnings, Adverse reactionsExact identifier
rxcui: 1811180
icosapent ethylICOSAPENT ETHYLSoftgel Healthcare Private Limited6f5838cd-4d17-401d-8e2a-652d0e73c1e92026-07-09Exact identifier
rxcui: 1811180
icosapent ethylICOSAPENT ETHYLZydus Pharmaceuticals USA Inc.5910742b-c5e6-4029-9a19-97669e3808bc2026-07-07Warnings, Adverse reactionsExact identifier
rxcui: 1811180
ICOSAPENT ETHYLICOSAPENT ETHYLEPIC PHARMA, LLC6db749b9-c817-41cd-909f-dd60a90c9f732026-06-05Warnings, Adverse reactionsExact identifier
rxcui: 1811180
ICOSAPENT ETHYLICOSAPENT ETHYLCamber Pharmaceuticals, Inc.3e3498ab-f35e-4597-8556-89bf9fdd14062026-04-30Warnings, Adverse reactionsExact identifier
rxcui: 1811180
ICOSAPENT ETHYLICOSAPENT ETHYLXLCare Pharmaceuticals, Inc.019cc0ac-0c2f-426d-996a-6d932f9544432026-04-30Warnings, Adverse reactionsExact identifier
rxcui: 1811180
VascepaICOSAPENT ETHYLAmarin Pharma Inc.9c1a2828-1583-4414-ab22-a60480e8e5082026-03-23Warnings, Adverse reactionsExact identifier
rxcui: 1811180
Icosapent ethylICOSAPENT ETHYLAmneal Pharmaceuticals LLCfd2b5373-1ddd-46c0-a579-d5a4f289d79f2025-03-11Warnings, Adverse reactionsExact identifier
rxcui: 1811180
Icosapent EthylICOSAPENT ETHYLTeva Pharmaceuticals, Inc.de7049ae-d1d6-4267-a93b-dd5039c50c2c2021-08-31Warnings, Adverse reactionsExact identifier
rxcui: 1811180

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 10 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
9c1a2828-1583-4414-ab22-a60480e8e508icosapent ethyl 0.5 GM Oral Capsule [PSN] · icosapent ethyl 500 MG Oral Capsule [SCD] · icosapent ethyl 0.5 GM Oral Capsule [SY]321These highlights do not include all the information needed to use VASCEPA ® safely and effectively. See full prescribing information for VASCEPA. VASCEPA ® (icosapent ethyl) capsules, for oral use Initial U.S. Approval: 201220260323
6db749b9-c817-41cd-909f-dd60a90c9f73icosapent ethyl 0.5 GM Oral Capsule [PSN] · icosapent ethyl 500 MG Oral Capsule [SCD] · icosapent ethyl 0.5 GM Oral Capsule [SY]34These 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: 201220260331
cdcee03e-5df1-a8fc-7490-dfdc624ce6d6icosapent ethyl 0.5 GM Oral Capsule [PSN] · icosapent ethyl 500 MG Oral Capsule [SCD] · icosapent ethyl 0.5 GM Oral Capsule [SY]34These 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: 201220230417
e3d38d1d-fbe7-413d-849a-675e7dfa9b0aicosapent ethyl 0.5 GM Oral Capsule [PSN] · icosapent ethyl 500 MG Oral Capsule [SCD] · icosapent ethyl 0.5 GM Oral Capsule [SY]34These 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: 201220230309
1a50bc22-bbdf-4ba8-b162-0e12f3e9d160icosapent ethyl 0.5 GM Oral Capsule [PSN] · icosapent ethyl 500 MG Oral Capsule [SCD] · icosapent ethyl 0.5 GM Oral Capsule [SY]33These 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: 201220250311
fd2b5373-1ddd-46c0-a579-d5a4f289d79ficosapent ethyl 0.5 GM Oral Capsule [PSN] · icosapent ethyl 500 MG Oral Capsule [SCD] · icosapent ethyl 0.5 GM Oral Capsule [SY]33These 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: 201220250311
5910742b-c5e6-4029-9a19-97669e3808bcicosapent ethyl 0.5 GM Oral Capsule [PSN] · icosapent ethyl 500 MG Oral Capsule [SCD] · icosapent ethyl 0.5 GM Oral Capsule [SY]33These 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: 201220250226
019cc0ac-0c2f-426d-996a-6d932f954443icosapent ethyl 0.5 GM Oral Capsule [PSN] · icosapent ethyl 500 MG Oral Capsule [SCD] · icosapent ethyl 0.5 GM Oral Capsule [SY]32These 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: 201220260430
3e3498ab-f35e-4597-8556-89bf9fdd1406icosapent ethyl 0.5 GM Oral Capsule [PSN] · icosapent ethyl 500 MG Oral Capsule [SCD] · icosapent ethyl 0.5 GM Oral Capsule [SY]32These 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: 201220260430
6f5838cd-4d17-401d-8e2a-652d0e73c1e9icosapent ethyl 0.5 GM Oral Capsule [PSN] · icosapent ethyl 500 MG Oral Capsule [SCD] · icosapent ethyl 0.5 GM Oral Capsule [SY]31ICOSAPENT ETHYL capsules, for oral use20241025