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 84 of 159 · 3,178 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medline Alcohol PrepISOPROPYL ALCOHOLMedline Industries, LPb43c0bff-82f8-c18d-e053-2995a90a87162025-10-16WarningsExact identifier
unii: ND2M416302
DD CreamDD CREAMDERMAdoctor, Inc.08c9a0cf-ee78-483b-e054-00144ff88e882025-10-16WarningsExact identifier
unii: 15FIX9V2JP
Ciele Filter and ProtectTITANIUM DIOXIDE, ZINC OXIDECiele0309b0ef-baca-b41d-e063-6294a90a49d72025-10-15WarningsExact identifier
unii: 15FIX9V2JP
Defend and Balance TInted Mineral Sunscreen SPF 50SUNSCREENEpicuren Discovery41367f05-59d8-6736-e063-6394a90a5f172025-10-15WarningsExact identifier
unii: 15FIX9V2JP
SEDLAVISOPROPYL ALCOHOLInstock Distributing1b31e3dc-31f3-dffe-e063-6394a90a1c962025-10-15WarningsExact identifier
unii: ND2M416302
SEDLAVISOPROPYL ALCOHOLInstock Distributing1c470960-f78d-19e7-e063-6294a90a49202025-10-15WarningsExact identifier
unii: ND2M416302
SEDLAVISOPROPYL ALCOHOLInstock Distributing1c477028-5cee-b8e2-e063-6394a90afb772025-10-15WarningsExact identifier
unii: ND2M416302
SEDLAVISOPROPYL ALCOHOLInstock Distributing1c472c35-e241-773f-e063-6294a90abb572025-10-15WarningsExact identifier
unii: ND2M416302
SEDLAVISOPROPYL ALCOHOL WIPESInstock Distributing1c478594-3118-048f-e063-6394a90a35d92025-10-15WarningsExact identifier
unii: ND2M416302
FinaftaBENZOCAINE, GLYCERINEfficient Laboratories Inc.03368603-3e11-c2fa-e063-6294a90a04ea2025-10-14WarningsExact identifier
unii: PDC6A3C0OX
Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE , ZINC OXIDESkinlycious Pte Ltde0ad02c3-f5ed-4b72-ba96-07d9c489a4ea2025-10-13WarningsExact identifier
unii: 15FIX9V2JP
EcoCare 350ISOPROPYL ALCOHOLEcolab Inc.77dab248-0f3e-4b7f-96e5-a60fc10c40d42025-10-10WarningsExact identifier
unii: ND2M416302
Kentex Alcohol Prep Pad Saturated with Isopropyl AlcoholISOPROPYL ALCOHOLKentron Healthcare, Inc.de7ffc63-bd14-42d8-b9fe-b7f8722b88822025-10-10WarningsExact identifier
unii: ND2M416302
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEEai-jr 286, Incb6c316c3-661b-6428-e053-2a95a90a1a6b2025-10-10WarningsExact identifier
unii: 15FIX9V2JP
CuradISOPROPYL ALCOHOLMedline Industries, LPc42de981-4e3f-1ac9-e053-2995a90aea982025-10-09WarningsExact identifier
unii: ND2M416302
GlycerinGLYCERINH E B3d0566a1-57a5-6a31-e054-00144ff88e882025-10-09WarningsExact identifier
unii: PDC6A3C0OX
Dr Lift Mineral SPF 50TITANIUM DIOXIDE, ZINC OXIDESpa de Soleil40c03d65-8d09-371a-e063-6294a90a7ac62025-10-09WarningsExact identifier
unii: 15FIX9V2JP
Dr Lift Mineral SPF 30TITANIUM DIOXIDESpa de Soleil40c0e0d2-2c1d-e629-e063-6394a90a5aaf2025-10-09WarningsExact identifier
unii: 15FIX9V2JP
STERILE ALCOHOL PREP PADS 01ISOPROPYL ALCOHOLTotal Resources International Inc.efd1b423-c5f5-0677-e053-2a95a90a23eb2025-10-09WarningsExact identifier
unii: ND2M416302
Essential Defense Mineral Shield Broad Spectrum SPF 35 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.29817fdc-f14c-4013-a8ed-4367f3b2867c2025-10-09WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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