FDA.reportPublic FDA data

Icosapent Ethyl

Product NDC
42291-046
Requested package NDC
42291-046-12
11-digit product format
422910046
Labeler code
42291
Product ID
42291-046_484c1be6-d44c-23ed-e063-6394a90acd5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Icosapent Ethyl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
AvKARE
Application
ANDA209525
Marketing category
ANDA
Marketing start
2023-12-05
Substance
ICOSAPENT ETHYL
Active strength
1 g/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42291-04642291-046-12IInactivated by FDA2026-07-31

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
A209525-001ICOSAPENT ETHYLICOSAPENT ETHYL500MGCAPSULE / ORALAB2020-09-11
A209525-002ICOSAPENT ETHYLICOSAPENT ETHYL1GMCAPSULE / ORALAB2020-09-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209525-001AB
A209525-002AB

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 22:54:322026-06A209525-001ICOSAPENT ETHYL500MGCAPSULE / ORALAB2020-09-11a50c72e98297…
2026-08-01 22:54:322026-06A209525-002ICOSAPENT ETHYL1GMCAPSULE / ORALAB2020-09-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209525-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A209525-002AB1a50c72e98297…

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 ETHYLTeva Pharmaceuticals, Inc.de7049ae-d1d6-4267-a93b-dd5039c50c2c2021-08-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209525
application number: ANDA209525

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
42291-046-12Icosapent Ethyl120 in 1 BOTTLECAPSULE, LIQUID FILLED1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-046-12EA - Each42291-0468573b7ca-a5cc-4ed5-a515-513ffb12600312024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-046ICOSAPENT ETHYL CAPSULE, LIQUID FILLED [AVKARE]1Current NDC, 1 package rows20231206_0bc72bd8-1f33-b01c-e063-6394a90a77ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1304979icosapent ethyl 1 GM Oral CapsulePSN0bc72bd8-1f33-b01c-e063-6394a90a77ea2
1304979icosapent ethyl 1000 MG Oral CapsuleSCD0bc72bd8-1f33-b01c-e063-6394a90a77ea2
1304979icosapent ethyl 1 GM Oral CapsuleSY0bc72bd8-1f33-b01c-e063-6394a90a77ea2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42291-046-1242291004612120 CAPSULE, LIQUID FILLED in 1 BOTTLE (42291-046-12) 2023-12-05NoNoHistorical