FDA.reportPublic FDA data

NDC 67184-0582-01 - Icosapent Ethyl

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
67184-0582
Requested NDC
67184-0582-01
Package NDCs from labels
67184-0582-1, 67184-0582-01
Manufacturer
Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd.(High-Tech Zone Site)
Effective date
2025-10-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Icosapent Ethyl - Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd.(High-Tech Zone Site)Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd.(High-Tech Zone Site)2025-10-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67184-0582-1Icosapent Ethyl120 in 1 BOTTLECAPSULE1201

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 18 · 356 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
Icosapent EthylICOSAPENT ETHYLBryant Ranch Prepack0ee78f22-bed2-48f8-9be8-b8f6ceeeaeaf2026-08-26Warnings, Adverse reactionsExact identifier
rxcui: 1304979
unii: 6GC8A4PAYH
Icosapent EthylICOSAPENT ETHYLBryant Ranch Prepack07631e74-48e5-46ec-b8db-4b1bcf62d2832026-08-25Warnings, Adverse reactionsExact identifier
rxcui: 1304979
unii: 6GC8A4PAYH
Icosapent EthylICOSAPENT ETHYLBryant Ranch Prepack582638e5-9881-409d-a455-041b5ba6892a2026-08-25Warnings, Adverse reactionsExact identifier
rxcui: 1304979
unii: 6GC8A4PAYH
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
IcosapentICOSAPENT ETHYLBryant Ranch Prepackcc28828d-beab-45cc-a3b6-151c5fee39242026-08-10Warnings, Adverse reactionsExact identifier
rxcui: 1304979
unii: 6GC8A4PAYH
Icosapent EthylICOSAPENT ETHYLBryant Ranch Prepackf9c1a6a6-cda4-49ea-97e9-0d3cf5ab5d4c2026-08-10Warnings, Adverse reactionsExact identifier
rxcui: 1304979
unii: 6GC8A4PAYH
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
unii: PDC6A3C0OX
Icosapent EthylICOSAPENT ETHYLNorthstar Rx LLC45f8bb41-bdb1-4afc-83ec-9dc69720ee9c2026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 1304979
unii: 6GC8A4PAYH
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX
Icosapent EthylICOSAPENT ETHYLDr. Reddy's Laboratories, Inc.cdcee03e-5df1-a8fc-7490-dfdc624ce6d62026-07-22Warnings, Adverse reactionsExact identifier
unii: 6GC8A4PAYH
IcosapentICOSAPENT ETHYLDr. Reddy's Laboratories, Inc.1aca884c-c464-900d-ac06-33aee7118df82026-07-22Warnings, Adverse reactionsExact identifier
rxcui: 1304979
unii: 6GC8A4PAYH
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: PDC6A3C0OX
PNV-OmegaASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENTAcella Pharmaceuticals, LLC735c5531-137f-4cee-8c68-ae121045a8ff2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H4N855PNZ1
Icosapent EthylICOSAPENT ETHYLHikma Pharmaceuticals USA Inc.e3d38d1d-fbe7-413d-849a-675e7dfa9b0a2026-07-09Warnings, Adverse reactionsExact identifier
rxcui: 1304979
unii: 6GC8A4PAYH
icosapent ethylICOSAPENT ETHYLSoftgel Healthcare Private Limited6f5838cd-4d17-401d-8e2a-652d0e73c1e92026-07-09Exact identifier
rxcui: 1304979
unii: 6GC8A4PAYH

Reported adverse events (FAERS/openFDA)#

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