Home NDC 64380-284 Icosapent ethyl
Product NDC 64380-284
11-digit product format 643800284
Labeler code 64380
Product ID 64380-284_7569c8d6-9fbf-4428-b274-6a803b3718a5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Icosapent ethyl
Dosage form CAPSULE
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA217844
Marketing category ANDA
Marketing start 2026-05-22
Substance ICOSAPENT ETHYL
Active strength .5 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217844-001 ICOSAPENT ETHYL ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-09-22 A217844-002 ICOSAPENT ETHYL ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-09-22
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.
Product history page 1 of 2 · 42 observed 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 A217844-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-09-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217844-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-09-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217844-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-09-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217844-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-09-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217844-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-09-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217844-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-09-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217844-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-09-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217844-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-09-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217844-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-09-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217844-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-09-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217844-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-09-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217844-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-09-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217844-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-09-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217844-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-09-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217844-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-09-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217844-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-09-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217844-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-09-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217844-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-09-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217844-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-09-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217844-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-09-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217844-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-09-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217844-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-09-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217844-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-09-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217844-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-09-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217844-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-09-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217844-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-09-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217844-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-09-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217844-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-09-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217844-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-09-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A217844-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-09-22 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217844-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-09-22 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217844-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-09-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217844-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-09-22 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A217844-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-09-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217844-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-09-22 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A217844-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-09-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217844-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-09-22 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217844-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-09-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217844-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-09-22 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217844-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-09-22 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64380-284-01 Icosapent ethyl 240 in 1 BOTTLE CAPSULE 240 3
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 · 1 matching rows.
DailyMed RxNorm Mappings# DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64380-284-01 64380028401 240 CAPSULE in 1 BOTTLE (64380-284-01) 240 capsule 2026-05-22 No No Historical