FDA.reportPublic FDA data

Icosapent Ethyl

Product NDC
0054-0621
11-digit product format
000540621
Labeler code
0054
Product ID
0054-0621_2417e4be-d579-4c3d-8ec0-a42dc51aabf5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Icosapent Ethyl
Dosage form
CAPSULE
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA209457
Marketing category
ANDA
Marketing start
2020-11-04
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
A209457-001ICOSAPENT ETHYLICOSAPENT ETHYL1GMCAPSULE / ORALAB2020-05-21
A209457-002ICOSAPENT ETHYLICOSAPENT ETHYL500MGCAPSULE / ORALAB2023-03-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209457-001AB
A209457-002AB

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 22:54:322026-06A209457-001ICOSAPENT ETHYL1GMCAPSULE / ORALAB2020-05-21a50c72e98297…
2026-08-01 22:54:322026-06A209457-002ICOSAPENT ETHYL500MGCAPSULE / ORALAB2023-03-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209457-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A209457-002AB1a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Icosapent EthylICOSAPENT ETHYLNorthstar Rx LLC45f8bb41-bdb1-4afc-83ec-9dc69720ee9c2026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209457
application number: ANDA209457
Icosapent EthylICOSAPENT ETHYLHikma Pharmaceuticals USA Inc.e3d38d1d-fbe7-413d-849a-675e7dfa9b0a2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209457
application number: ANDA209457
ndc (product): 0054-0621
Icosapent EthylICOSAPENT ETHYLBryant Ranch Prepack07631e74-48e5-46ec-b8db-4b1bcf62d2832026-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209457
application number: ANDA209457
Icosapent EthylICOSAPENT ETHYLBryant Ranch Prepack582638e5-9881-409d-a455-041b5ba6892a2025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209457
application number: ANDA209457
Icosapent EthylICOSAPENT ETHYLBryant Ranch Prepack0ee78f22-bed2-48f8-9be8-b8f6ceeeaeaf2024-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209457
application number: ANDA209457
Icosapent EthylICOSAPENT ETHYLBryant Ranch Prepackf9c1a6a6-cda4-49ea-97e9-0d3cf5ab5d4c2024-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209457
application number: ANDA209457

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
e3d38d1d-fbe7-413d-849a-675e7dfa9b0aAvailable 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
0054-0621-27Icosapent Ethyl240 in 1 BOTTLECAPSULE2404

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0621-27EA - Each0054-062124d425da-6209-4dac-8e7d-841f0bfffd0c12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0621ICOSAPENT ETHYL CAPSULE [HIKMA PHARMACEUTICALS USA INC.]4Current NDC, 1 package rows20230314_e3d38d1d-fbe7-413d-849a-675e7dfa9b0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1811180icosapent ethyl 0.5 GM Oral CapsulePSNe3d38d1d-fbe7-413d-849a-675e7dfa9b0a4
1304979icosapent ethyl 1 GM Oral CapsulePSNe3d38d1d-fbe7-413d-849a-675e7dfa9b0a4
1304979icosapent ethyl 1000 MG Oral CapsuleSCDe3d38d1d-fbe7-413d-849a-675e7dfa9b0a4
1811180icosapent ethyl 500 MG Oral CapsuleSCDe3d38d1d-fbe7-413d-849a-675e7dfa9b0a4
1811180icosapent ethyl 0.5 GM Oral CapsuleSYe3d38d1d-fbe7-413d-849a-675e7dfa9b0a4
1304979icosapent ethyl 1 GM Oral CapsuleSYe3d38d1d-fbe7-413d-849a-675e7dfa9b0a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0054-0621-2700054062127240 CAPSULE in 1 BOTTLE (0054-0621-27) 240 capsule2023-03-09NoNoCurrent