Home NDC 60429-005 Icosapent Ethyl
Product NDC 60429-005
11-digit product format 604290005
Labeler code 60429
Product ID 60429-005_36370268-ebc0-8ab1-e063-6394a90adc9e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Icosapent Ethyl
Dosage form CAPSULE
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA209437
Marketing category ANDA
Marketing start 2021-06-30
Substance ICOSAPENT ETHYL
Active strength 1 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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209437-001 ICOSAPENT ETHYL ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209437-001 AB
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 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Icosapent Ethyl
Listing expiration 2026-12-31 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 60429-005-12 Icosapent Ethyl 120 in 1 BOTTLE CAPSULE 120 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 · 3 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 60429-005-12 60429000512 120 CAPSULE in 1 BOTTLE (60429-005-12) 120 capsule 2025-03-31 No No Current