Icosapent Ethyl

Product NDC: 42291-046
11-digit product format: 422910046
Labeler code: 42291
Product ID: 42291-046_484c1be6-d44c-23ed-e063-6394a90acd5d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Icosapent Ethyl
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: AvKARE
Application: ANDA209525
Marketing category: ANDA
Marketing start: 2023-12-05
Substance: ICOSAPENT ETHYL
Active strength: 1 g/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42291-046		I	Inactivated by FDA		2026-08-17
excluded package	package	42291-046	42291-046-12	I	Inactivated by FDA		2026-08-17

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.

Application-product, TE code table
Application-product	TE code
A209525-001	AB
A209525-002	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.

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209525-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209525-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209525-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209525-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209525-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209525-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209525-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209525-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209525-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209525-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209525-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209525-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209525-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209525-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209525-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209525-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209525-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209525-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209525-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209525-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209525-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209525-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209525-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209525-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209525-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209525-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209525-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209525-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209525-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209525-002	AB	1	`8072bd15b7f6…`
2021-03-12 10:30 UTC	2021-03	A209525-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209525-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209525-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209525-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209525-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209525-002	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209525-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209525-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209525-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209525-002	AB	1	`1c564ffb4f44…`

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f6766515-27b8-72de-2010-167151236ace	Product name	7	20251021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42291-046-12	Icosapent Ethyl	120 in 1 BOTTLE	CAPSULE, LIQUID FILLED	120		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-046-12	EA - Each	42291-046	8573b7ca-a5cc-4ed5-a515-513ffb126003	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-046	ICOSAPENT ETHYL CAPSULE, LIQUID FILLED [AVKARE]	1	Current NDC, 1 package rows	20231206_0bc72bd8-1f33-b01c-e063-6394a90a77ea.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Icosapent Ethyl	ICOSAPENT ETHYL	Teva Pharmaceuticals, Inc.	de7049ae-d1d6-4267-a93b-dd5039c50c2c	2021-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209525 application number: ANDA209525

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6GC8A4PAYH	ICOSAPENT ETHYL	86227-47-6	ICOSAPENT ETHYL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1304979	icosapent ethyl 1 GM Oral Capsule	PSN	0bc72bd8-1f33-b01c-e063-6394a90a77ea	2
1304979	icosapent ethyl 1000 MG Oral Capsule	SCD	0bc72bd8-1f33-b01c-e063-6394a90a77ea	2
1304979	icosapent ethyl 1 GM Oral Capsule	SY	0bc72bd8-1f33-b01c-e063-6394a90a77ea	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
42291-046-12	42291004612	120 CAPSULE, LIQUID FILLED in 1 BOTTLE (42291-046-12)	2023-12-05	No	No	Historical