FDA.reportPublic FDA data

icosapent ethyl 1000 MG Oral Capsule [Vascepa]

RxCUI
1304985
RxNorm name
icosapent ethyl 1000 MG Oral Capsule [Vascepa]
Display name
VASCEPA (Oral Pill)
Full name
icosapent ethyl 1000 MG Oral Capsule [Vascepa]
Term type
SBD
Status
Active
Strength
1,000 mg
Dose form
Cap
Route
Oral Pill
Updated
2026-07-21 06:57:20

RxNorm Status History#

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

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#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRVascepa 1 GM Oral CapsuleNAMES
RxNorm Nameicosapent ethyl 1000 MG Oral Capsule [Vascepa]NAMES
RxNorm SynonymVascepa 1 GM Oral CapsuleNAMES
RxNorm SynonymVascepa 1000 MG Oral CapsuleNAMES
TTYSBDATTRIBUTES
SPL_SET_ID9c1a2828-1583-4414-ab22-a60480e8e508CODES
SPL_SET_IDd245ddab-d81b-44bd-90d7-0e4d446d9bf5CODES
RxCUI1304985CODES
MMSL_CODEBD27811CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
52937-001-2052937-001Vascepa icosapent ethylAmarin Pharma Inc.NDA202057
52937-005-2052937-005Vascepa icosapent ethylAmarin Pharma Inc.NDA202057
52937-101-0852937-101Vascepa icosapent ethylAmarin Pharma Inc.NDA202057
63629-8247-163629-8247Vascepa icosapent ethylBryant Ranch PrepackNDA202057
63629-8247-263629-8247Vascepa icosapent ethylBryant Ranch PrepackNDA202057
63629-8247-363629-8247Vascepa icosapent ethylBryant Ranch PrepackNDA202057
63629-8247-463629-8247Vascepa icosapent ethylBryant Ranch PrepackNDA202057

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA20205752937-001Vascepa icosapent ethylNDAAmarin Pharma Inc.

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
52937000104rxnav_ndcsyes
52937000120rxnav_ndcsyes
52937000121rxnav_ndcsyes
52937000520rxnav_ndcsyes
52937010108rxnav_ndcsyes
63629824701rxnav_ndcsyes
63629824702rxnav_ndcsyes
63629824703rxnav_ndcsyes
63629824704rxnav_ndcsyes

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
9c1a2828-1583-4414-ab22-a60480e8e508icosapent ethyl 1000 MG Oral Capsule [Vascepa]SBD21These 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
9c1a2828-1583-4414-ab22-a60480e8e508Vascepa 1 GM Oral CapsuleSY21These 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
9c1a2828-1583-4414-ab22-a60480e8e508Vascepa 1000 MG Oral CapsuleSY21These 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
9c1a2828-1583-4414-ab22-a60480e8e508Vascepa 1 GM Oral CapsulePSN21These 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 1000 MG Oral Capsule [Vascepa]SBD7These 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
d245ddab-d81b-44bd-90d7-0e4d446d9bf5Vascepa 1000 MG Oral CapsuleSY7These 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
d245ddab-d81b-44bd-90d7-0e4d446d9bf5Vascepa 1 GM Oral CapsulePSN7These 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
d245ddab-d81b-44bd-90d7-0e4d446d9bf5Vascepa 1 GM Oral CapsuleSY7These 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

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
d245ddab-d81b-44bd-90d7-0e4d446d9bf5These 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: 2012Bryant Ranch Prepack20260407
9c1a2828-1583-4414-ab22-a60480e8e508These 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: 2012Amarin Pharma Inc.20260323
9c1a2828-1583-4414-ab22-a60480e8e508These 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: 2012Amarin Pharma Inc.20251216

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
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSBD
CODESMMSL_CODEBD27811
CODESNDANDA202057
CODESRxCUI1304985
CODESSPL_SET_ID9c1a2828-1583-4414-ab22-a60480e8e508
CODESSPL_SET_IDd245ddab-d81b-44bd-90d7-0e4d446d9bf5
NAMESPrescribable SynonymVascepa 1 GM Oral Capsule
NAMESRXNAV_STRVascepa 1 GM Oral Capsule
NAMESRxNorm Nameicosapent ethyl 1000 MG Oral Capsule [Vascepa]
NAMESRxNorm SynonymVascepa 1 GM Oral Capsule
NAMESRxNorm SynonymVascepa 1000 MG Oral Capsule
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon