FDA.reportPublic FDA data

ICOSAPENT ETHYL

Product NDC
72865-289
11-digit product format
728650289
Labeler code
72865
Product ID
72865-289_e78f8ff5-3e0a-44d1-b64f-19a912bd0a34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Icosapent ethyl
Dosage form
CAPSULE
Route
ORAL
Labeler
XLCare Pharmaceuticals, Inc.
Application
ANDA216811
Marketing category
ANDA
Marketing start
2024-02-16
Substance
ICOSAPENT ETHYL
Active strength
.5 g/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
A216811-001ICOSAPENT ETHYLICOSAPENT ETHYL500MGCAPSULE / ORALAB2023-12-07
A216811-002ICOSAPENT ETHYLICOSAPENT ETHYL1GMCAPSULE / ORALAB2024-02-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216811-001AB
A216811-002AB

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 22:54:322026-06A216811-001ICOSAPENT ETHYL500MGCAPSULE / ORALAB2023-12-07a50c72e98297…
2026-08-01 22:54:322026-06A216811-002ICOSAPENT ETHYL1GMCAPSULE / ORALAB2024-02-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A216811-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A216811-002AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ICOSAPENT ETHYLICOSAPENT ETHYLCamber Pharmaceuticals, Inc.3e3498ab-f35e-4597-8556-89bf9fdd14062026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216811
application number: ANDA216811
ICOSAPENT ETHYLICOSAPENT ETHYLXLCare Pharmaceuticals, Inc.019cc0ac-0c2f-426d-996a-6d932f9544432026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216811
application number: ANDA216811
ndc (product): 72865-289
ICOSAPENT ETHYLICOSAPENT ETHYLBryant Ranch Prepackb4a1ca8a-2d22-4c54-9193-eab4e75ba7db2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216811
application number: ANDA216811
ICOSAPENT ETHYLICOSAPENT ETHYLNorthstar Rx LLCb5b0b1ae-29ab-43a5-9e6d-24374d9613992025-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216811
application number: ANDA216811

Additional Listing Data#

Finished product
Yes
Brand name base
ICOSAPENT ETHYL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ICOSAPENT ETHYL.5 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6GC8A4PAYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1304979Internal RxNorm lookup
1811180Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
019cc0ac-0c2f-426d-996a-6d932f954443Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f6766515-27b8-72de-2010-167151236aceProduct name720251021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72865-289-24ICOSAPENT ETHYL240 in 1 BOTTLECAPSULE2402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-289-24EA - Each72865-2893d00e6d5-481b-4634-83da-a76c790f12f612024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-289ICOSAPENT ETHYL CAPSULE [XLCARE PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20240322_019cc0ac-0c2f-426d-996a-6d932f954443.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1811180icosapent ethyl 0.5 GM Oral CapsulePSN019cc0ac-0c2f-426d-996a-6d932f9544432
1304979icosapent ethyl 1 GM Oral CapsulePSN019cc0ac-0c2f-426d-996a-6d932f9544432
1304979icosapent ethyl 1000 MG Oral CapsuleSCD019cc0ac-0c2f-426d-996a-6d932f9544432
1811180icosapent ethyl 500 MG Oral CapsuleSCD019cc0ac-0c2f-426d-996a-6d932f9544432
1811180icosapent ethyl 0.5 GM Oral CapsuleSY019cc0ac-0c2f-426d-996a-6d932f9544432
1304979icosapent ethyl 1 GM Oral CapsuleSY019cc0ac-0c2f-426d-996a-6d932f9544432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72865-289-2472865028924240 CAPSULE in 1 BOTTLE (72865-289-24) 240 capsule2024-02-16NoNoCurrent