Home NDC 42806-559 ICOSAPENT ETHYL
Product NDC 42806-559
11-digit product format 428060559
Labeler code 42806
Product ID 42806-559_61751e3a-6f7b-4725-9d8b-7dc9c7d8558e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name icosapent ethyl
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler EPIC PHARMA, LLC
Application ANDA217919
Marketing category ANDA
Marketing start 2023-12-22
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 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217919-001 ICOSAPENT ETHYL ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-22 A217919-002 ICOSAPENT ETHYL ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-12-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A217919-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217919-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-12-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217919-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217919-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217919-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217919-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217919-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217919-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217919-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217919-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217919-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217919-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217919-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217919-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217919-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217919-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217919-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217919-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217919-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217919-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217919-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217919-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217919-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217919-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217919-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217919-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217919-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217919-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217919-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A217919-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-12-22 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217919-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-22 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217919-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-12-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217919-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-22 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A217919-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-12-22 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217919-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217919-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-12-22 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base ICOSAPENT ETHYL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ICOSAPENT ETHYL .5 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6GC8A4PAYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1304979 Internal RxNorm lookup 1811180 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42806-559-24 ICOSAPENT ETHYL 240 in 1 BOTTLE CAPSULE, LIQUID FILLED 240 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-559 ICOSAPENT ETHYL CAPSULE, LIQUID FILLED [EPIC PHARMA, LLC] 3 Current NDC, 1 package rows 20240815_6db749b9-c817-41cd-909f-dd60a90c9f73.zip
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 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 42806-559-24 42806055924 240 CAPSULE, LIQUID FILLED in 1 BOTTLE (42806-559-24) 2023-12-22 No No Current