icosapent ethyl 500 MG Oral Capsule

RxCUI
1811180
RxNorm name
icosapent ethyl 500 MG Oral Capsule
Display name
Icosapent ethyl (Oral Pill)
Full name
icosapent ethyl 500 MG Oral Capsule
Term type
SCD
Status
Active
Strength
500 mg
Dose form
Cap
Route
Oral Pill
Updated
2026-10-24 12:48:42

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
112016
Active start
112016
Multiple ingredient
NO
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
icosapent ethyl500 MG / 1 EACHicosapent ethylicosapent ethyl

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Capsule316965

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
icosapent ethyl1304974

Source Vocabulary Codes#

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0054-0621-270054-0621Icosapent Ethyl Icosapent EthylHikma Pharmaceuticals USA Inc.ANDA209457
0480-0126-490480-0126Icosapent Ethyl Icosapent EthylTeva Pharmaceuticals, Inc.ANDA209525
31722-298-2431722-298ICOSAPENT ETHYL Icosapent ethylCamber Pharmaceuticals, Inc.ANDA216811
35916-1738-135916-1738icosapent ethyl icosapent ethylSoftgel Healthcare Private LimitedANDA217656
42806-559-2442806-559ICOSAPENT ETHYL icosapent ethylEPIC PHARMA, LLCANDA217919
43598-746-7243598-746Icosapent Ethyl Icosapent EthylDr. Reddy's Laboratories, Inc.ANDA209499
69238-2597-769238-2597Icosapent ethyl Icosapent ethylAmneal Pharmaceuticals LLCANDA217844
70710-1738-470710-1738icosapent ethyl icosapent ethylZydus Pharmaceuticals USA Inc.ANDA217656
72865-289-2472865-289ICOSAPENT ETHYL Icosapent ethylXLCare Pharmaceuticals, Inc.ANDA216811

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA2094570054-0621Icosapent Ethyl Icosapent EthylANDAHikma Pharmaceuticals USA Inc.
ANDA2095250480-0126Icosapent Ethyl Icosapent EthylANDATeva Pharmaceuticals, Inc.
ANDA21681131722-298ICOSAPENT ETHYL Icosapent ethylANDACamber Pharmaceuticals, Inc.
ANDA21765635916-1738icosapent ethyl icosapent ethylANDASoftgel Healthcare Private Limited
ANDA21791942806-559ICOSAPENT ETHYL icosapent ethylANDAEPIC PHARMA, LLC
ANDA20949943598-746Icosapent Ethyl Icosapent EthylANDADr. Reddy's Laboratories, Inc.
ANDA21784469238-2597Icosapent ethyl Icosapent ethylANDAAmneal Pharmaceuticals LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 12 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00054062127rxnav_ndcsyes
00480012649rxnav_ndcsyes
31722029824rxnav_ndcsyes
35916173801rxnav_ndcsyes
42806055924rxnav_ndcsyes
43598074672rxnav_ndcsyes
64380028401rxnav_ndcsyes
69238259707rxnav_ndcsyes
70710173804rxnav_ndcsyes
72865028924rxnav_ndcsyes
43602054705rxnav_historical
43602054730rxnav_historical

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
ndc (package): 43598-746-72
ndc (product): 43598-746
ndc11 (package): 43598074672
rxcui: 1811180
Icosapent EthylICOSAPENT ETHYLHikma Pharmaceuticals USA Inc.e3d38d1d-fbe7-413d-849a-675e7dfa9b0a2026-07-09Warnings, Adverse reactionsExact identifier
ndc (package): 0054-0621-27
ndc (product): 0054-0621
ndc11 (package): 00054062127
rxcui: 1811180
icosapent ethylICOSAPENT ETHYLSoftgel Healthcare Private Limited6f5838cd-4d17-401d-8e2a-652d0e73c1e92026-07-09Exact identifier
ndc (package): 35916-1738-1
ndc (product): 35916-1738
ndc11 (package): 35916173801
rxcui: 1811180
icosapent ethylICOSAPENT ETHYLZydus Pharmaceuticals USA Inc.5910742b-c5e6-4029-9a19-97669e3808bc2026-07-07Warnings, Adverse reactionsExact identifier
ndc (package): 70710-1738-4
ndc (product): 70710-1738
ndc11 (package): 70710173804
rxcui: 1811180
ICOSAPENT ETHYLICOSAPENT ETHYLEPIC PHARMA, LLC6db749b9-c817-41cd-909f-dd60a90c9f732026-06-05Warnings, Adverse reactionsExact identifier
ndc (package): 42806-559-24
ndc (product): 42806-559
ndc11 (package): 42806055924
rxcui: 1811180
ICOSAPENT ETHYLICOSAPENT ETHYLCamber Pharmaceuticals, Inc.3e3498ab-f35e-4597-8556-89bf9fdd14062026-04-30Warnings, Adverse reactionsExact identifier
ndc (package): 31722-298-24
ndc (product): 31722-298
ndc11 (package): 31722029824
rxcui: 1811180
ICOSAPENT ETHYLICOSAPENT ETHYLXLCare Pharmaceuticals, Inc.019cc0ac-0c2f-426d-996a-6d932f9544432026-04-30Warnings, Adverse reactionsExact identifier
ndc (package): 72865-289-24
ndc (product): 72865-289
ndc11 (package): 72865028924
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
ndc (package): 69238-2597-7
ndc (product): 69238-2597
ndc11 (package): 69238259707
rxcui: 1811180
Icosapent EthylICOSAPENT ETHYLTeva Pharmaceuticals, Inc.de7049ae-d1d6-4267-a93b-dd5039c50c2c2021-08-27Warnings, Adverse reactionsExact identifier
ndc (package): 0480-0126-49
ndc (product): 0480-0126
ndc11 (package): 00480012649
rxcui: 1811180

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
cdcee03e-5df1-a8fc-7490-dfdc624ce6d6These 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: 2012Dr. Reddy's Laboratories, Inc.20260722
cdcee03e-5df1-a8fc-7490-dfdc624ce6d6These 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: 2012Dr. Reddy's Laboratories, Inc.20260713
e3d38d1d-fbe7-413d-849a-675e7dfa9b0aThese 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: 2012Hikma Pharmaceuticals USA Inc.20260709
6f5838cd-4d17-401d-8e2a-652d0e73c1e9ICOSAPENT ETHYL capsules, for oral useSoftgel Healthcare Private Limited20260709
5910742b-c5e6-4029-9a19-97669e3808bcThese 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: 2012Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Global FZE | Doppel Farmaceutici S.r.l. | Softgel Healthcare Private Limited20260707
6db749b9-c817-41cd-909f-dd60a90c9f73These 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: 2012EPIC PHARMA, LLC | Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd20260605
019cc0ac-0c2f-426d-996a-6d932f954443These 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: 2012XLCare Pharmaceuticals, Inc. | Ascent Pharmaceuticals, Inc20260430
3e3498ab-f35e-4597-8556-89bf9fdd1406These 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: 2012Camber Pharmaceuticals, Inc. | Ascent Pharmaceuticals, Inc20260430
6db749b9-c817-41cd-909f-dd60a90c9f73These 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: 2012EPIC PHARMA, LLC | Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd20260331
fd2b5373-1ddd-46c0-a579-d5a4f289d79fThese 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: 2012Amneal Pharmaceuticals LLC | Strides Pharma Global Pte. Ltd. | Strides Pharma Science Limited20250311
1a50bc22-bbdf-4ba8-b162-0e12f3e9d160These 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: 2012Strides Pharma Science Limited | Strides Pharma Global Pte. Ltd.20250311
5910742b-c5e6-4029-9a19-97669e3808bcThese 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: 2012Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Global FZE | Doppel Farmaceutici S.r.l. | Softgel Healthcare Private Limited20250226
6f5838cd-4d17-401d-8e2a-652d0e73c1e9ICOSAPENT ETHYL capsules, for oral useSoftgel Healthcare Private Limited20241025
5c84fe3c-68d3-4906-a133-132b8c5e9eb0These 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: 2012Ascent Pharmaceuticals, Inc20240304
cdcee03e-5df1-a8fc-7490-dfdc624ce6d6These 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: 2012Dr. Reddy's Laboratories, Inc.20230417
e3d38d1d-fbe7-413d-849a-675e7dfa9b0aThese 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: 2012Hikma Pharmaceuticals USA Inc.20230309
de7049ae-d1d6-4267-a93b-dd5039c50c2cThese 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: 2012Teva Pharmaceuticals, Inc.20210831
de7049ae-d1d6-4267-a93b-dd5039c50c2cThese 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: 2012Teva Pharmaceuticals, Inc.20210827
de7049ae-d1d6-4267-a93b-dd5039c50c2cThese 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: 2012Teva Pharmaceuticals, Inc.20210801
de7049ae-d1d6-4267-a93b-dd5039c50c2cThese 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: 2012Teva Pharmaceuticals, Inc.20210801

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
MEDRTD015118Eicosapentaenoic AcidCHEMhas_ingredienticosapent ethyl

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH500 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA209457
CODESANDAANDA209499
CODESANDAANDA209525
CODESANDAANDA216811
CODESANDAANDA217656
CODESANDAANDA217844
CODESANDAANDA217919
CODESVUID4036129
NAMESPrescribable Synonymicosapent ethyl 0.5 GM Oral Capsule
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File