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, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRVascepa 1 GM Oral Capsule1NAMES
RxNorm Nameicosapent ethyl 1000 MG Oral Capsule [Vascepa]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI13049851CODES
MMSL_CODEBD278111CODES

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#

RxNav current and historical NDC rows page 1 of 1 · 9 matching rows.

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

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VascepaICOSAPENT ETHYLBryant Ranch Prepackd245ddab-d81b-44bd-90d7-0e4d446d9bf52026-04-07Warnings, Adverse reactionsExact identifier
ndc (package): 63629-8247-1
ndc (package): 63629-8247-4
ndc (package): 63629-8247-3
ndc (package): 63629-8247-2
ndc (product): 63629-8247
ndc11 (package): 63629824703
ndc11 (package): 63629824704
ndc11 (package): 63629824701
ndc11 (package): 63629824702
rxcui: 1304985
VascepaICOSAPENT ETHYLAmarin Pharma Inc.9c1a2828-1583-4414-ab22-a60480e8e5082026-03-23Warnings, Adverse reactionsExact identifier
ndc (package): 52937-101-08
ndc (package): 52937-001-20
ndc (package): 52937-005-20
ndc (product): 52937-001
ndc (product): 52937-101
ndc (product): 52937-005
ndc11 (package): 52937000121
ndc11 (package): 52937010108
ndc11 (package): 52937000120
ndc11 (package): 52937000104
ndc11 (package): 52937000520
rxcui: 1304985

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
9c1a2828-1583-4414-ab22-a60480e8e508Vascepa 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [Vascepa] [SBD] · Vascepa 1 GM Oral Capsule [SY] · Vascepa 1000 MG Oral Capsule [SY]421These 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-90d7-0e4d446d9bf5Vascepa 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [Vascepa] [SBD] · Vascepa 1 GM Oral Capsule [SY] · Vascepa 1000 MG Oral Capsule [SY]47These 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

Recently Linked 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
e251bdc4-2fb9-442b-a34c-598eadb6ea4fNational Council for Prescription Drug Programs20130213

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
CODESNDANDA202057
NAMESPrescribable SynonymVascepa 1 GM Oral Capsule
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon