Home NDC 60687-764-21 Icosapent Ethyl
Product NDC 60687-764
Requested package NDC 60687-764-21
11-digit product format 606870764
Labeler code 60687
Product ID 60687-764_47a64acc-3806-d861-e063-6394a90a8d02
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Icosapent Ethyl
Dosage form CAPSULE
Route ORAL
Labeler American Health Packaging
Application ANDA209437
Marketing category ANDA
Marketing start 2024-02-21
Marketing end 2027-05-31
Substance ICOSAPENT ETHYL
Active strength 1 g/1
NDC exclude flag No
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 · 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 2026-02-19 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 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 60687-764-11 Icosapent Ethyl 1 in 1 BLISTER PACK CAPSULE 1 5 60687-764-21 Icosapent Ethyl 30 in 1 CARTON CAPSULE 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60687-764 ICOSAPENT ETHYL CAPSULE [AMERICAN HEALTH PACKAGING] 3 Current NDC, 2 package rows 20240328_fd28217d-5817-43b0-8185-7c7ec6da83f3.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 Units Marketing start Marketing end Sample Exclude flag Status 60687-764-21 60687076421 30 BLISTER PACK in 1 CARTON (60687-764-21) / 1 CAPSULE in 1 BLISTER PACK (60687-764-11) 30 blister pack 2024-02-21 2027-05-31 No No Historical