Home NDC 63629-9312 Icosapent
Product NDC 63629-9312
11-digit product format 636299312
Labeler code 63629
Product ID 63629-9312_8988eb81-87de-4d83-8d5a-f9e0d2863618
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Icosapent Ethyl
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA209499
Marketing category ANDA
Marketing start 2021-06-21
Marketing end 2027-09-30
Substance ICOSAPENT ETHYL
Active strength 1000 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 A209499-001 ICOSAPENT ETHYL ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 A209499-002 ICOSAPENT ETHYL ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-03-08
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 · 62 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 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209499-002 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-03-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209499-002 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-03-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209499-002 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-03-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209499-002 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-03-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209499-002 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-03-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209499-002 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-03-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209499-002 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-03-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209499-002 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-03-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209499-002 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-03-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209499-002 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-03-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209499-002 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-03-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209499-002 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-03-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209499-002 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-03-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209499-002 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-03-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209499-002 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-03-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 6a51e52b5d6a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 62 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Icosapent Active Ingredients# Ingredient, Strength table Ingredient Strength ICOSAPENT ETHYL 1000 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 · 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 63629-9312-1 Icosapent 120 in 1 BOTTLE CAPSULE 120 102
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-9312 ICOSAPENT (ICOSAPENT ETHYL) CAPSULE [BRYANT RANCH PREPACK] 102 Current NDC, Legacy NDC, 1 package rows 20240116_cc28828d-beab-45cc-a3b6-151c5fee3924.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 63629-9312-1 63629931201 120 CAPSULE in 1 BOTTLE (63629-9312-1) 120 capsule 2022-07-06 0000-00-00 No No Current