icosapent ethyl 1000 MG Oral Capsule

RxCUI
1304979
RxNorm name
icosapent ethyl 1000 MG Oral Capsule
Display name
Icosapent ethyl (Oral Pill)
Full name
icosapent ethyl 1000 MG Oral Capsule
Term type
SCD
Status
Active
Strength
1,000 mg
Dose form
Cap
Route
Oral Pill
Updated
2026-07-21 06:57:13

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
092012
Active start
092012
Multiple ingredient
NO
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
icosapent ethyl1000 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
0054-0508-230054-0508Icosapent Ethyl Icosapent EthylHikma Pharmaceuticals USA Inc.ANDA209457
0480-0127-890480-0127Icosapent Ethyl Icosapent EthylTeva Pharmaceuticals, Inc.ANDA209525
13668-761-1213668-761Icosapent Ethyl Icosapent Ethyl CapsulesTorrent Pharmaceuticals LimitedANDA218994
16714-636-0116714-636ICOSAPENT ETHYL Icosapent ethylNorthstar Rx LLCANDA216811
31722-299-1231722-299ICOSAPENT ETHYL Icosapent ethylCamber Pharmaceuticals, Inc.ANDA216811
35916-1592-135916-1592icosapent ethyl icosapent ethylSoftgel Healthcare Private LimitedANDA217656
42291-046-1242291-046Icosapent Ethyl Icosapent EthylAvKAREANDA209525
42806-560-1242806-560ICOSAPENT ETHYL icosapent ethylEPIC PHARMA, LLCANDA217919
43598-267-0443598-267Icosapent Icosapent EthylDr. Reddy's Laboratories, Inc.ANDA209499
60429-005-1260429-005Icosapent Ethyl Icosapent EthylGolden State Medical Supply, Inc.ANDA209437
60505-4033-160505-4033Icosapent Ethyl Icosapent EthylApotex CorpANDA209437
60687-764-2160687-764Icosapent Ethyl Icosapent EthylAmerican Health PackagingANDA209437
63629-9311-163629-9311Icosapent Ethyl Icosapent EthylBryant Ranch PrepackANDA209457
63629-9312-163629-9312Icosapent Icosapent EthylBryant Ranch PrepackANDA209499
64380-285-0164380-285Icosapent ethyl Icosapent ethylStrides Pharma Science LimitedANDA217844
67184-0582-167184-0582Icosapent Ethyl Icosapent EthylQilu Pharmaceutical Co., Ltd.ANDA218899
69238-2598-869238-2598Icosapent ethyl Icosapent ethylAmneal Pharmaceuticals LLCANDA217844
69680-186-9269680-186Icosapent Ethyl Icosapent EthylVitruvias Therapeutics, Inc.ANDA219156
70710-1592-770710-1592icosapent ethyl icosapent ethylZydus Pharmaceuticals USA Inc.ANDA217656
71335-2842-171335-2842Icosapent Ethyl Icosapent EthylBryant Ranch PrepackANDA209457
71335-2989-171335-2989ICOSAPENT ETHYL Icosapent ethylBryant Ranch PrepackANDA216811
71335-2989-271335-2989ICOSAPENT ETHYL Icosapent ethylBryant Ranch PrepackANDA216811
71335-2989-371335-2989ICOSAPENT ETHYL Icosapent ethylBryant Ranch PrepackANDA216811
71335-2989-471335-2989ICOSAPENT ETHYL Icosapent ethylBryant Ranch PrepackANDA216811
71335-3072-171335-3072Icosapent Ethyl Icosapent EthylBryant Ranch PrepackANDA209457
71335-3072-271335-3072Icosapent Ethyl Icosapent EthylBryant Ranch PrepackANDA209457
71335-3072-371335-3072Icosapent Ethyl Icosapent EthylBryant Ranch PrepackANDA209457
71335-3072-471335-3072Icosapent Ethyl Icosapent EthylBryant Ranch PrepackANDA209457
72162-1000-272162-1000Icosapent Ethyl Icosapent EthylBryant Ranch PrepackANDA209457
72603-129-0172603-129Icosapent Ethyl Icosapent EthylNorthstar Rx LLCANDA209457
72865-290-1272865-290ICOSAPENT ETHYL Icosapent ethylXLCare Pharmaceuticals, Inc.ANDA216811

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA2094570054-0508Icosapent Ethyl Icosapent EthylANDAHikma Pharmaceuticals USA Inc.
ANDA2095250480-0127Icosapent Ethyl Icosapent EthylANDATeva Pharmaceuticals, Inc.
ANDA21899413668-761Icosapent Ethyl Icosapent Ethyl CapsulesANDATorrent Pharmaceuticals Limited
ANDA21681116714-636ICOSAPENT ETHYL Icosapent ethylANDANorthstar Rx LLC
ANDA21765635916-1592icosapent ethyl icosapent ethylANDASoftgel Healthcare Private Limited
ANDA21791942806-560ICOSAPENT ETHYL icosapent ethylANDAEPIC PHARMA, LLC
ANDA20949943598-267Icosapent Icosapent EthylANDADr. Reddy's Laboratories, Inc.
ANDA20943760429-005Icosapent Ethyl Icosapent EthylANDAGolden State Medical Supply, Inc.
ANDA21784464380-285Icosapent ethyl Icosapent ethylANDAStrides Pharma Science Limited
ANDA21889967184-0582Icosapent Ethyl Icosapent EthylANDAQilu Pharmaceutical Co., Ltd.
ANDA21915669680-186Icosapent Ethyl Icosapent EthylANDAVitruvias Therapeutics, Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 42 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00054050823rxnav_ndcsyes
00480012789rxnav_ndcsyes
13668076112rxnav_ndcsyes
16714063601rxnav_ndcsyes
31722029912rxnav_ndcsyes
35916159201rxnav_ndcsyes
42291003212rxnav_ndcsyes
42291004612rxnav_ndcsyes
42806056012rxnav_ndcsyes
42806057612rxnav_ndcsyes
43598026704rxnav_ndcsyes
60429000512rxnav_ndcsyes
60505403301rxnav_ndcsyes
60505403303rxnav_ndcsyes
60687076411rxnav_ndcsyes
60687076421rxnav_ndcsyes
63629931101rxnav_ndcsyes
63629931201rxnav_ndcsyes
64380028501rxnav_ndcsyes
67184058201rxnav_ndcsyes
69238259808rxnav_ndcsyes
69680018692rxnav_ndcsyes
70710159207rxnav_ndcsyes
71335284201rxnav_ndcsyes
71335298901rxnav_ndcsyes
71335298902rxnav_ndcsyes
71335298903rxnav_ndcsyes
71335298904rxnav_ndcsyes
71335307201rxnav_ndcsyes
71335307202rxnav_ndcsyes
71335307203rxnav_ndcsyes
71335307204rxnav_ndcsyes
71335314801rxnav_ndcsyes
71335314802rxnav_ndcsyes
71335314803rxnav_ndcsyes
71335314804rxnav_ndcsyes
72162100002rxnav_ndcsyes
72603012901rxnav_ndcsyes
72865029012rxnav_ndcsyes
35916095801rxnav_historical
43602029105rxnav_historical
43602029130rxnav_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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Icosapent EthylICOSAPENT ETHYLNorthstar Rx LLC45f8bb41-bdb1-4afc-83ec-9dc69720ee9c2026-07-29Warnings, Adverse reactionsExact identifier
ndc (package): 72603-129-01
ndc (product): 72603-129
ndc11 (package): 72603012901
rxcui: 1304979
IcosapentICOSAPENT ETHYLDr. Reddy's Laboratories, Inc.1aca884c-c464-900d-ac06-33aee7118df82026-07-22Warnings, Adverse reactionsExact identifier
ndc (package): 43598-267-04
ndc (product): 43598-267
ndc11 (package): 43598026704
rxcui: 1304979
Icosapent EthylICOSAPENT ETHYLHikma Pharmaceuticals USA Inc.e3d38d1d-fbe7-413d-849a-675e7dfa9b0a2026-07-09Warnings, Adverse reactionsExact identifier
ndc (package): 0054-0508-23
ndc (product): 0054-0508
ndc11 (package): 00054050823
rxcui: 1304979
icosapent ethylICOSAPENT ETHYLSoftgel Healthcare Private Limited6f5838cd-4d17-401d-8e2a-652d0e73c1e92026-07-09Exact identifier
ndc (package): 35916-1592-1
ndc (product): 35916-1592
ndc11 (package): 35916159201
rxcui: 1304979
icosapent ethylICOSAPENT ETHYLZydus Pharmaceuticals USA Inc.5910742b-c5e6-4029-9a19-97669e3808bc2026-07-07Warnings, Adverse reactionsExact identifier
ndc (package): 70710-1592-7
ndc (product): 70710-1592
ndc11 (package): 70710159207
rxcui: 1304979
Icosapent ethylICOSAPENT ETHYLAurobindo Pharma Limitedb30afc7a-bffb-4c71-974f-1d977156eb462026-06-26Warnings, Adverse reactionsExact identifier
rxcui: 1304979
ICOSAPENT ETHYLICOSAPENT ETHYLBryant Ranch Prepackb6e361cc-c314-4402-9361-2d977788e93c2026-06-18Warnings, Adverse reactionsExact identifier
ndc11 (package): 71335314804
ndc11 (package): 71335314802
ndc11 (package): 71335314803
ndc11 (package): 71335314801
rxcui: 1304979
ICOSAPENT ETHYLICOSAPENT ETHYLEPIC PHARMA, LLC30574162-0e84-4352-b7fa-42fc20115d682026-06-05Warnings, Adverse reactionsExact identifier
ndc11 (package): 42806057612
rxcui: 1304979
ICOSAPENT ETHYLICOSAPENT ETHYLEPIC PHARMA, LLC6db749b9-c817-41cd-909f-dd60a90c9f732026-06-05Warnings, Adverse reactionsExact identifier
ndc (package): 42806-560-12
ndc (product): 42806-560
ndc11 (package): 42806056012
rxcui: 1304979
ICOSAPENT ETHYLICOSAPENT ETHYLCamber Pharmaceuticals, Inc.3e3498ab-f35e-4597-8556-89bf9fdd14062026-04-30Warnings, Adverse reactionsExact identifier
ndc (package): 31722-299-12
ndc (product): 31722-299
ndc11 (package): 31722029912
rxcui: 1304979
ICOSAPENT ETHYLICOSAPENT ETHYLXLCare Pharmaceuticals, Inc.019cc0ac-0c2f-426d-996a-6d932f9544432026-04-30Warnings, Adverse reactionsExact identifier
ndc (package): 72865-290-12
ndc (product): 72865-290
ndc11 (package): 72865029012
rxcui: 1304979
Icosapent EthylICOSAPENT ETHYL CAPSULESTorrent Pharmaceuticals Limited24105b33-bbb7-4349-a5d0-8fe4af7e49942026-04-22Warnings, Adverse reactionsExact identifier
ndc (package): 13668-761-12
ndc (product): 13668-761
ndc11 (package): 13668076112
rxcui: 1304979
VascepaICOSAPENT ETHYLBryant Ranch Prepackd245ddab-d81b-44bd-90d7-0e4d446d9bf52026-04-07Warnings, Adverse reactionsExact identifier
rxcui: 1304979
Icosapent EthylICOSAPENT ETHYLApotex Corp886aa8d8-b293-258f-b16d-be40418787a82026-03-31Warnings, Adverse reactionsExact identifier
ndc (package): 60505-4033-1
ndc (product): 60505-4033
ndc11 (package): 60505403301
ndc11 (package): 60505403303
rxcui: 1304979
VascepaICOSAPENT ETHYLAmarin Pharma Inc.9c1a2828-1583-4414-ab22-a60480e8e5082026-03-23Warnings, Adverse reactionsExact identifier
rxcui: 1304979
Icosapent EthylICOSAPENT ETHYLBryant Ranch Prepack07631e74-48e5-46ec-b8db-4b1bcf62d2832026-02-09Warnings, Adverse reactionsExact identifier
ndc (package): 71335-3072-3
ndc (package): 71335-3072-4
ndc (package): 71335-3072-1
ndc (package): 71335-3072-2
ndc (product): 71335-3072
ndc11 (package): 71335307202
ndc11 (package): 71335307204
ndc11 (package): 71335307201
ndc11 (package): 71335307203
rxcui: 1304979
ICOSAPENT ETHYLICOSAPENT ETHYLBryant Ranch Prepackb4a1ca8a-2d22-4c54-9193-eab4e75ba7db2026-02-04Warnings, Adverse reactionsExact identifier
ndc (package): 71335-2989-3
ndc (package): 71335-2989-4
ndc (package): 71335-2989-1
ndc (package): 71335-2989-2
ndc (product): 71335-2989
ndc11 (package): 71335298904
ndc11 (package): 71335298903
ndc11 (package): 71335298902
ndc11 (package): 71335298901
rxcui: 1304979
Icosapent EthylICOSAPENT ETHYLAmerican Health Packagingfd28217d-5817-43b0-8185-7c7ec6da83f32026-01-05Warnings, Adverse reactionsExact identifier
ndc (package): 60687-764-21
ndc (product): 60687-764
ndc11 (package): 60687076421
ndc11 (package): 60687076411
rxcui: 1304979
Icosapent EthylICOSAPENT ETHYLQilu Pharmaceutical Co., Ltd.20686acb-66c5-4d75-9684-7474436e8bef2025-10-30Warnings, Adverse reactionsExact identifier
ndc (package): 67184-0582-1
ndc (product): 67184-0582
ndc11 (package): 67184058201
rxcui: 1304979
Icosapent EthylICOSAPENT ETHYLVitruvias Therapeutics, Inc.4c3e26d6-9297-42ad-94b4-04e394155b412025-10-21Warnings, Adverse reactionsExact identifier
ndc (package): 69680-186-92
ndc (product): 69680-186
ndc11 (package): 69680018692
rxcui: 1304979

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 26 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
cc28828d-beab-45cc-a3b6-151c5fee3924icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY]3102These 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: 201220240115
f9c1a6a6-cda4-49ea-97e9-0d3cf5ab5d4cicosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY]3102These 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: 201220240115
582638e5-9881-409d-a455-041b5ba6892aicosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY]3100These 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: 201220251021
0ee78f22-bed2-48f8-9be8-b8f6ceeeaeaficosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY]3100These 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: 201220241224
9c1a2828-1583-4414-ab22-a60480e8e508icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 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
d245ddab-d81b-44bd-90d7-0e4d446d9bf5icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY]37These 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: 201220260407
886aa8d8-b293-258f-b16d-be40418787a8icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY]36These 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
fd28217d-5817-43b0-8185-7c7ec6da83f3icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY]35These 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: 201220260105
6db749b9-c817-41cd-909f-dd60a90c9f73icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 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
e3d38d1d-fbe7-413d-849a-675e7dfa9b0aicosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 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 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 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 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 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 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 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
1aca884c-c464-900d-ac06-33aee7118df8icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 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: 201220210628
019cc0ac-0c2f-426d-996a-6d932f954443icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 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 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 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
0bc72bd8-1f33-b01c-e063-6394a90a77eaicosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY]32Icosapent Ethyl Capsules Rx Only 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: 201220260113
45f8bb41-bdb1-4afc-83ec-9dc69720ee9cicosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 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: 201220231222
24105b33-bbb7-4349-a5d0-8fe4af7e4994icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY]31These 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: 201220260422
07631e74-48e5-46ec-b8db-4b1bcf62d283icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY]31These 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: 201220260209
b4a1ca8a-2d22-4c54-9193-eab4e75ba7dbicosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY]31These 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: 201220260204
20686acb-66c5-4d75-9684-7474436e8beficosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY]31These 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: 201220251030
4c3e26d6-9297-42ad-94b4-04e394155b41icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY]31These 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: 201220251021
3637187f-70bc-eb31-e063-6294a90ad3cbicosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY]31ICOSAPENT ETHYL CAPSULES. 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: 201220250528
b5b0b1ae-29ab-43a5-9e6d-24374d961399icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY]31These 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: 201220250305
6f5838cd-4d17-401d-8e2a-652d0e73c1e9icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY]31ICOSAPENT ETHYL capsules, for oral use20241025

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
cc28828d-beab-45cc-a3b6-151c5fee3924These 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: 2012Bryant Ranch Prepack20260810
f9c1a6a6-cda4-49ea-97e9-0d3cf5ab5d4cThese 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: 2012Bryant Ranch Prepack20260810
45f8bb41-bdb1-4afc-83ec-9dc69720ee9cThese 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: 2012Northstar Rx LLC20260729
1aca884c-c464-900d-ac06-33aee7118df8These 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
1aca884c-c464-900d-ac06-33aee7118df8These 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
b6e361cc-c314-4402-9361-2d977788e93cThese 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: 2012Bryant Ranch Prepack20260618
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
30574162-0e84-4352-b7fa-42fc20115d68These 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
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
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
24105b33-bbb7-4349-a5d0-8fe4af7e4994These 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: 2012Torrent Pharmaceuticals Limited20260422
886aa8d8-b293-258f-b16d-be40418787a8These 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: 2012Apotex Corp | Apotex Inc.20260331
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
07631e74-48e5-46ec-b8db-4b1bcf62d283These 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: 2012Bryant Ranch Prepack20260209
b4a1ca8a-2d22-4c54-9193-eab4e75ba7dbThese 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: 2012Bryant Ranch Prepack20260204
0bc72bd8-1f33-b01c-e063-6394a90a77eaIcosapent Ethyl Capsules Rx Only 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: 2012AvKARE20260113
fd28217d-5817-43b0-8185-7c7ec6da83f3These 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: 2012American Health Packaging20260105
fd28217d-5817-43b0-8185-7c7ec6da83f3These 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: 2012American Health Packaging20251113
20686acb-66c5-4d75-9684-7474436e8befThese 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: 2012Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd.(High-Tech Zone Site)20251030
582638e5-9881-409d-a455-041b5ba6892aThese 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: 2012Bryant Ranch Prepack20251021
4c3e26d6-9297-42ad-94b4-04e394155b41These 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: 2012Vitruvias Therapeutics, Inc.20251021
3637187f-70bc-eb31-e063-6294a90ad3cbICOSAPENT ETHYL CAPSULES. 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: 2012Golden State Medical Supply, Inc.20250528
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
b5b0b1ae-29ab-43a5-9e6d-24374d961399These 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: 2012Northstar Rx LLC | Ascent Pharmaceuticals, Inc20250305
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
0ee78f22-bed2-48f8-9be8-b8f6ceeeaeafThese 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: 2012Bryant Ranch Prepack20241224
6f5838cd-4d17-401d-8e2a-652d0e73c1e9ICOSAPENT ETHYL capsules, for oral useSoftgel Healthcare Private Limited20241025
07a8174b-f0ed-c277-e063-6394a90a9eb1These 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: 2012Softgel Healthcare Private Limited20240606
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
0fb2eb8a-e308-0177-e063-6294a90a7418ICOSAPENT 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: 2012AvKARE20240124
cc28828d-beab-45cc-a3b6-151c5fee3924These 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: 2012Bryant Ranch Prepack20240115
f9c1a6a6-cda4-49ea-97e9-0d3cf5ab5d4cThese 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: 2012Bryant Ranch Prepack20240115
45f8bb41-bdb1-4afc-83ec-9dc69720ee9cThese 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: 2012Northstar Rx LLC20231222
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.20210801

Drug Classes#

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

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH1000 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA209437
CODESANDAANDA209457
CODESANDAANDA209499
CODESANDAANDA209525
CODESANDAANDA216811
CODESANDAANDA217656
CODESANDAANDA217844
CODESANDAANDA217919
CODESANDAANDA218899
CODESANDAANDA218994
CODESANDAANDA219156
CODESVUID4032045
NAMESPrescribable Synonymicosapent ethyl 1 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