Home NDC 71335-2989 ICOSAPENT ETHYL
Product NDC 71335-2989
11-digit product format 713352989
Labeler code 71335
Product ID 71335-2989_9df091ac-075e-456c-9f09-faf11d1c4b0a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Icosapent ethyl
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA216811
Marketing category ANDA
Marketing start 2024-02-16
Substance ICOSAPENT ETHYL
Active strength 1 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 43 .
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 A216811-001 ICOSAPENT ETHYL ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-07 A216811-002 ICOSAPENT ETHYL ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2024-02-16
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 2026-09-14 22:38:34 2026-08 A216811-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216811-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2024-02-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216811-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216811-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2024-02-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216811-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216811-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2024-02-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216811-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216811-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2024-02-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216811-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216811-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2024-02-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216811-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216811-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2024-02-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216811-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216811-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2024-02-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216811-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216811-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2024-02-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216811-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216811-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2024-02-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216811-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216811-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2024-02-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216811-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216811-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2024-02-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216811-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216811-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2024-02-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216811-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216811-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2024-02-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216811-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216811-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2024-02-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216811-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216811-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2024-02-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216811-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216811-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2024-02-16 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216811-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-07 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216811-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2024-02-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216811-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-07 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216811-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-12-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216811-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2024-02-16 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-2989-1 ICOSAPENT ETHYL 30 in 1 BOTTLE CAPSULE 30 1 71335-2989-2 ICOSAPENT ETHYL 60 in 1 BOTTLE CAPSULE 60 1 71335-2989-3 ICOSAPENT ETHYL 120 in 1 BOTTLE CAPSULE 120 1 71335-2989-4 ICOSAPENT ETHYL 90 in 1 BOTTLE CAPSULE 90 1
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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71335-2989-1 71335298901 30 CAPSULE in 1 BOTTLE (71335-2989-1) 30 capsule 2026-02-04 No No Current 71335-2989-2 71335298902 60 CAPSULE in 1 BOTTLE (71335-2989-2) 60 capsule 2026-02-04 No No Current 71335-2989-3 71335298903 120 CAPSULE in 1 BOTTLE (71335-2989-3) 120 capsule 2026-02-04 No No Current 71335-2989-4 71335298904 90 CAPSULE in 1 BOTTLE (71335-2989-4) 90 capsule 2026-02-04 No No Current