FDA.reportPublic FDA data

NDC 64380-285 - 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
64380-285
Package NDCs from labels
64380-285-01
Manufacturer
Strides Pharma Science Limited | Strides Pharma Global Pte. Ltd.
Effective date
2025-03-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ICOSAPENT - Strides Pharma Science Limited | Strides Pharma Global Pte. Ltd.Strides Pharma Science Limited | Strides Pharma Global Pte. Ltd.2025-03-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-285-01Icosapent ethyl120 in 1 BOTTLECAPSULE1203

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 13 of 161 · 3,214 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol prep padISOPROPYL ALCOHOL CLOTHHubei V-Medical Products co.,Ltd.51d5780e-9039-1b66-e063-6394a90a0b8a2026-05-15WarningsExact identifier
unii: ND2M416302
LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUMTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc.23cc5ff4-f842-4e3e-ac5c-23dbaf7d39142026-05-15WarningsExact identifier
unii: 15FIX9V2JP
LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUMTITANIUM DIOXIDE AND ZINC OXIDESICOS ET CIEc688f8e6-2cd2-40db-b03f-90fd74c2d89c2026-05-15WarningsExact identifier
unii: 15FIX9V2JP
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc7df9dbd2-7db9-4961-819d-e93d14a065c32026-05-15WarningsExact identifier
unii: 15FIX9V2JP
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE20efd5fa-3077-4fd4-82d0-ddca946e45282026-05-15WarningsExact identifier
unii: 15FIX9V2JP
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.4e91983f-4570-3a56-e063-6394a90a38f22026-05-15WarningsExact identifier
unii: ND2M416302
Swab Applicator Brushes 2% w/w chlorhexidine gluconate (CHG) and 70% v/v isopropyI alcohol (IPA)CHLORHEXIDINE GLUCONATE, ISOPROPYI ALCOHOLXINXIANG XINDA TECHNOLOGY CO.,LTD51c34af0-2b12-c5e0-e063-6394a90a41742026-05-14WarningsExact identifier
unii: ND2M416302
MELAO Hydrating Lightweight SunscreenOCTOCRYLENE,HOMOSALATE,ETHYLHEXYL SALICYLATE,PHENYLBENZIMIDAZOLE SULFONIC ACID,BUTYL METHOXYDIBENZOYLMETHANE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd51c353cb-94c4-e110-e063-6394a90a497e2026-05-14WarningsExact identifier
unii: 15FIX9V2JP
Isopropyl AlcoholISOPROPYL ALCOHOLChain Drug Marketing Associationf5b99c4b-1f4b-40be-bae7-59aa92c5b52c2026-05-14Warnings, Adverse reactionsExact identifier
unii: ND2M416302
HEMORRHOIDAL WITH LIDOCAINEGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY, INC4d870c68-9e72-464e-b0b8-900d0d661e432026-05-14WarningsExact identifier
unii: PDC6A3C0OX
91% Isopropyl AlcoholISOPROPYL ALCOHOLChain Drug Marketing Associationf10995fd-fe94-436a-8783-4cdf10438d752026-05-14Warnings, Adverse reactionsExact identifier
unii: ND2M416302
70% Isopropyl AlcoholISOPROPYL ALCOHOLChain Drug Marketing Associationc07b7f1b-eda2-4f0f-a35d-f34ac85abab32026-05-14Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLHARRIS TEETERb3fa1454-25cd-4801-bbec-5da43a70ec7f2026-05-14WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLHARRIS TEETERc4e816c7-a8a2-404c-9354-eaaed6dbf0f52026-05-14WarningsExact identifier
unii: ND2M416302
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3
Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - DarkTITANIUM DIOXIDE AND ZINC OXIDESENT, Inc.aedde765-931f-430e-9fc3-d87bde2b78cd2026-05-12WarningsExact identifier
unii: 15FIX9V2JP
Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - MediumTITANIUM DIOXIDE AND ZINC OXIDESENT, Inc.417305d7-d32e-4bc9-8f77-0a42b6bdecf52026-05-12WarningsExact identifier
unii: 15FIX9V2JP
Lightning X Sting and Bite Relief PadsBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.518698c0-a1ae-760f-e063-6394a90a51602026-05-11WarningsExact identifier
unii: ND2M416302
The Perfect Derma Mineral Perfection Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEBella Medical Products LLC518f69fc-fd39-8195-e063-6294a90a3fdd2026-05-11WarningsExact identifier
unii: 15FIX9V2JP
Radical Rescue Morning UVA/UVB Defense Primer Broad Spectrum SPF 30 Universal Tint Mineral SunscreenRADICAL RESCUE SPF 30 MINERAL SUNSCREENProTransit, Inc.38e0139c-bb87-55ba-e063-6294a90a82ee2026-05-11WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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