FDA.reportPublic FDA data

Icosapent ethyl

Product NDC
64380-284
11-digit product format
643800284
Labeler code
64380
Product ID
64380-284_7569c8d6-9fbf-4428-b274-6a803b3718a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Icosapent ethyl
Dosage form
CAPSULE
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA217844
Marketing category
ANDA
Marketing start
2026-05-22
Substance
ICOSAPENT ETHYL
Active strength
.5 g/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217844-001ICOSAPENT ETHYLICOSAPENT ETHYL500MGCAPSULE / ORALAB2023-09-22
A217844-002ICOSAPENT ETHYLICOSAPENT ETHYL1GMCAPSULE / ORALAB2023-09-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A217844-001AB
A217844-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A217844-001ICOSAPENT ETHYL500MGCAPSULE / ORALAB2023-09-22a50c72e98297…
2026-08-01 22:54:322026-06A217844-002ICOSAPENT ETHYL1GMCAPSULE / ORALAB2023-09-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A217844-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A217844-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Icosapent ethylICOSAPENT ETHYLAmneal Pharmaceuticals LLCfd2b5373-1ddd-46c0-a579-d5a4f289d79f2025-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217844
application number: ANDA217844

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f6766515-27b8-72de-2010-167151236aceProduct name720251021
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-284-01Icosapent ethyl240 in 1 BOTTLECAPSULE2403

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1811180icosapent ethyl 0.5 GM Oral CapsulePSN1a50bc22-bbdf-4ba8-b162-0e12f3e9d1603
1304979icosapent ethyl 1 GM Oral CapsulePSN1a50bc22-bbdf-4ba8-b162-0e12f3e9d1603
1304979icosapent ethyl 1000 MG Oral CapsuleSCD1a50bc22-bbdf-4ba8-b162-0e12f3e9d1603
1811180icosapent ethyl 500 MG Oral CapsuleSCD1a50bc22-bbdf-4ba8-b162-0e12f3e9d1603
1811180icosapent ethyl 0.5 GM Oral CapsuleSY1a50bc22-bbdf-4ba8-b162-0e12f3e9d1603
1304979icosapent ethyl 1 GM Oral CapsuleSY1a50bc22-bbdf-4ba8-b162-0e12f3e9d1603

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1811180icosapent ethyl 0.5 GM Oral CapsulePSN1a50bc22-bbdf-4ba8-b162-0e12f3e9d1603
1304979icosapent ethyl 1 GM Oral CapsulePSN1a50bc22-bbdf-4ba8-b162-0e12f3e9d1603
1304979icosapent ethyl 1000 MG Oral CapsuleSCD1a50bc22-bbdf-4ba8-b162-0e12f3e9d1603
1811180icosapent ethyl 500 MG Oral CapsuleSCD1a50bc22-bbdf-4ba8-b162-0e12f3e9d1603
1811180icosapent ethyl 0.5 GM Oral CapsuleSY1a50bc22-bbdf-4ba8-b162-0e12f3e9d1603
1304979icosapent ethyl 1 GM Oral CapsuleSY1a50bc22-bbdf-4ba8-b162-0e12f3e9d1603

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64380-284-0164380028401240 CAPSULE in 1 BOTTLE (64380-284-01) 240 capsule2026-05-22NoNoHistorical