Home NDC 0480-0126 Icosapent Ethyl
Product NDC 0480-0126
11-digit product format 004800126
Labeler code 0480
Product ID 0480-0126_0d2afdd4-3333-47dc-9653-0b63e478b36d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Icosapent Ethyl
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Teva Pharmaceuticals, Inc.
Application ANDA209525
Marketing category ANDA
Marketing start 2022-09-09
Substance ICOSAPENT ETHYL
Active strength 500 mg/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 A209525-001 ICOSAPENT ETHYL ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2020-09-11 A209525-002 ICOSAPENT ETHYL ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-09-11
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 · 76 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 A209525-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2020-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209525-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-09-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209525-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2020-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209525-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-09-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209525-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2020-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209525-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-09-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209525-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2020-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209525-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-09-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209525-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2020-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209525-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-09-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209525-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2020-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209525-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-09-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209525-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2020-09-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209525-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-09-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209525-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2020-09-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209525-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-09-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209525-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2020-09-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209525-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-09-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209525-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2020-09-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209525-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-09-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209525-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2020-09-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209525-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-09-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209525-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2020-09-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209525-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-09-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209525-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2020-09-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209525-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-09-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209525-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2020-09-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209525-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-09-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209525-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2020-09-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209525-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-09-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209525-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL 2020-09-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209525-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL 2020-09-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209525-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL 2020-09-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209525-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL 2020-09-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209525-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL 2020-09-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209525-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL 2020-09-11 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A209525-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL 2020-09-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A209525-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL 2020-09-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209525-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL 2020-09-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A209525-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL 2020-09-11 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 59 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2023-12-20 04:57 UTC 2023-12 A209525-001 PC 2023-03-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209525-001 PC 2023-03-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209525-001 PC 2023-03-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209525-001 PC 2023-03-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209525-001 PC 2023-03-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209525-001 PC 2023-03-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209525-001 PC 2023-03-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209525-001 PC 2023-03-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209525-001 PC 2023-03-08 f41ea6bd6efb…
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 500 mg/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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1304979 Internal RxNorm lookup 1811180 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 0480-0126-49 Icosapent Ethyl 240 in 1 BOTTLE CAPSULE, LIQUID FILLED 240 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0480-0126 ICOSAPENT ETHYL CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20250112_de7049ae-d1d6-4267-a93b-dd5039c50c2c.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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0480-0126-49 00480012649 240 CAPSULE, LIQUID FILLED in 1 BOTTLE (0480-0126-49) 2022-09-09 0000-00-00 No No Current