Icosapent Ethyl

Product NDC: 60505-4033
Requested package NDC: 60505-4033-1
11-digit product format: 605054033
Labeler code: 60505
Product ID: 60505-4033_131d2bd6-c27a-36af-da0f-2102b32e1e06
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Icosapent Ethyl
Dosage form: CAPSULE
Route: ORAL
Labeler: Apotex Corp
Application: ANDA209437
Marketing category: ANDA
Marketing start: 2021-12-16
Marketing end: 2027-08-31
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 43.

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A209437-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2021-06-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209437-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2021-06-30	`caaa826d4ba7…`
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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209437-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209437-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209437-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209437-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209437-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209437-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209437-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209437-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209437-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209437-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209437-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209437-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209437-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209437-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209437-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209437-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209437-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209437-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209437-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209437-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209437-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209437-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209437-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209437-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209437-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209437-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209437-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209437-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209437-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209437-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209437-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209437-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209437-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209437-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209437-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Icosapent Ethyl

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ICOSAPENT ETHYL	1 g/1

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
60505-4033-1	Icosapent Ethyl	120 in 1 BOTTLE	CAPSULE	120		6
60505-4033-3	Icosapent Ethyl	30 in 1 BOTTLE	CAPSULE	30		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-4033-1	EA - Each	60505-4033	feef2866-1a34-4578-9f19-f3bb8d1b7d20	1	2022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-4033	ICOSAPENT ETHYL CAPSULE [APOTEX CORP]	5	Current NDC, Legacy NDC, 2 package rows	20250529_886aa8d8-b293-258f-b16d-be40418787a8.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Icosapent Ethyl	ICOSAPENT ETHYL	Golden State Medical Supply, Inc.	3637187f-70bc-eb31-e063-6294a90ad3cb	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209437 application number: ANDA209437
Icosapent Ethyl	ICOSAPENT ETHYL	Apotex Corp	886aa8d8-b293-258f-b16d-be40418787a8	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209437 application number: ANDA209437 ndc (package): 60505-4033-1 ndc (product): 60505-4033 ndc11 (package): 60505403301
Icosapent Ethyl	ICOSAPENT ETHYL	American Health Packaging	fd28217d-5817-43b0-8185-7c7ec6da83f3	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209437 application number: ANDA209437

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	886aa8d8-b293-258f-b16d-be40418787a8	6
1304979	icosapent ethyl 1000 MG Oral Capsule	SCD	886aa8d8-b293-258f-b16d-be40418787a8	6
1304979	icosapent ethyl 1 GM Oral Capsule	SY	886aa8d8-b293-258f-b16d-be40418787a8	6
1304979	icosapent ethyl 1 GM Oral Capsule	PSN	fd28217d-5817-43b0-8185-7c7ec6da83f3	5
1304979	icosapent ethyl 1000 MG Oral Capsule	SCD	fd28217d-5817-43b0-8185-7c7ec6da83f3	5
1304979	icosapent ethyl 1 GM Oral Capsule	SY	fd28217d-5817-43b0-8185-7c7ec6da83f3	5
1304979	icosapent ethyl 1 GM Oral Capsule	PSN	3637187f-70bc-eb31-e063-6294a90ad3cb	1
1304979	icosapent ethyl 1000 MG Oral Capsule	SCD	3637187f-70bc-eb31-e063-6294a90ad3cb	1
1304979	icosapent ethyl 1 GM Oral Capsule	SY	3637187f-70bc-eb31-e063-6294a90ad3cb	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-4033-1	60505403301	120 CAPSULE in 1 BOTTLE (60505-4033-1)	120 capsule	2021-12-16	2027-08-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Icosapent Ethyl	Apotex Corp \| Apotex Inc.	2026-09-28	HUMAN PRESCRIPTION DRUG LABEL	7
Icosapent Ethyl	Golden State Medical Supply, Inc.	2026-06-16	HUMAN PRESCRIPTION DRUG LABEL	2
Icosapent Ethyl	American Health Packaging	2026-01-05	HUMAN PRESCRIPTION DRUG LABEL	5