FDA.reportPublic FDA data

omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule

RxCUI
577208
RxNorm name
omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule
Display name
omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule
Full name
omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:05

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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSREMEDYREPACK INC.9e041905-40a7-4d5b-af1c-6c544e0748b92026-09-03Warnings, Adverse reactionsExact identifier
rxcui: 577208
omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSStrides Pharma Science Limited9499c40e-6665-4fbf-914d-1a9931b935622026-09-02Warnings, Adverse reactionsExact identifier
rxcui: 577208
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSMajor Pharmaceuticalse40d55f2-db9f-4a48-8639-9aa7491e4de52026-05-21Warnings, Adverse reactionsExact identifier
rxcui: 577208
Omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSCamber Pharmaceuticals, Inc.0d842966-26bc-4521-b401-635a836180122026-04-30Warnings, Adverse reactionsExact identifier
rxcui: 577208
Omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSXLCare Pharmaceuticals, Inc.18947318-31b4-42fb-83be-8f1bfe732e952026-04-30Warnings, Adverse reactionsExact identifier
rxcui: 577208
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSREMEDYREPACK INC.c6b35b2d-5a65-4fc4-8a2c-af7b3aea3eee2026-04-27Warnings, Adverse reactionsExact identifier
rxcui: 577208
Omega-3-Acid Ethyl EstersOMEGA-3-ACID ETHYL ESTERSGolden State Medical Supply, Inc.11d744aa-cc06-1206-e063-6294a90a49c92026-04-06Warnings, Adverse reactionsExact identifier
rxcui: 577208
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSLifestar Pharma LLC769ad170-5d70-4a54-995a-fef95ef503eb2026-02-13Warnings, Adverse reactionsExact identifier
rxcui: 577208
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSA-S Medication Solutions6fea8860-3c63-435f-a5b0-4281364ebd092026-01-20Warnings, Adverse reactionsExact identifier
rxcui: 577208
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSA-S Medication Solutions4eef8b47-8185-4d93-9b2a-1200b953a6e32026-01-20Warnings, Adverse reactionsExact identifier
rxcui: 577208
omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSChartwell RX, LLC331d5d9d-58d8-4b4f-8114-b28efa7276d72025-12-22Warnings, Adverse reactionsExact identifier
rxcui: 577208
omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSAmerican Health Packaging294ee73f-849c-4c3d-a415-d66138c91f532025-04-29Warnings, Adverse reactionsExact identifier
rxcui: 577208
Omega-3-Acid Ethyl EstersOMEGA-3-ACID ETHYL ESTERSKD Pharma USA, Inc.d1fd2a28-befb-4a09-b516-0c01bc4c8c6c2025-02-10Warnings, Adverse reactionsExact identifier
rxcui: 577208
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSKD Pharma USA, Inc.5cf3091e-4a88-4799-a88a-d53a5bc1de572025-02-10Warnings, Adverse reactionsExact identifier
rxcui: 577208
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS52d4fc86-227a-4a74-9f42-50fd184714d82025-01-08Warnings, Adverse reactionsExact identifier
rxcui: 577208
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSEPIC PHARMA, LLC787f9929-ef31-42a7-a305-8ba343e396722025-01-07Warnings, Adverse reactionsExact identifier
rxcui: 577208
Omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSBryant Ranch Prepack7d75287f-6f09-43b0-9b38-150685236d472024-12-27Warnings, Adverse reactionsExact identifier
rxcui: 577208
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSNCS HealthCare of KY, LLC dba Vangard Labsc293de7f-b4b6-461b-a0eb-470e5b84618d2024-10-18Warnings, Adverse reactionsExact identifier
rxcui: 577208
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSBryant Ranch Prepackc8dc6c4a-ed19-4727-ba5a-35075f1ddddf2024-08-08Warnings, Adverse reactionsExact identifier
rxcui: 577208
Omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSA-S Medication Solutions730e47e0-d2eb-46c5-8be7-1d0cd5b4a6fa2024-02-18Warnings, Adverse reactionsExact identifier
rxcui: 577208

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 2 of 2 · 43 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
c9f470e5-ef40-4316-a767-a6d8866834d2omega-3 acid ethyl esters 1 GM Oral Capsule [PSN] · omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule [SCD] · omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule [SY]31These highlights do not include all the information needed to use Omega-3-acid ethyl esters safely and effectively. See full prescribing information for Omega-3-acid ethyl esters capsules. Omega-3-Acid Ethyl Esters Capsules, USP for oral use Initial U.S. Approval: 200420210301
ff4a8e34-360b-4a9d-b8d2-d3cf447b6338omega-3 acid ethyl esters 1 GM Oral Capsule [PSN] · omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule [SCD] · omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule [SY]31Omega-3 Rx Complete20190117
fa9a1060-5d12-4d8e-9d39-5bf6fddc25b9omega-3 acid ethyl esters 1 GM Oral Capsule [PSN] · omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule [SCD] · omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule [SY]3120160412