Home NDC 42806-576 ICOSAPENT ETHYL
Product NDC 42806-576
11-digit product format 428060576
Labeler code 42806
Product ID 42806-576_30574162-0e84-4352-b7fa-42fc20115d68
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 1 g/1
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-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 2026-02-19 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 1 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1304979 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Status 42806-576-12 42806057612 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (42806-576-12) 2026-05-27 0 Current