Icosapent Ethyl

Product NDC: 0054-0508
Requested package NDC: 0054-0508-23
11-digit product format: 000540508
Labeler code: 0054
Product ID: 0054-0508_2417e4be-d579-4c3d-8ec0-a42dc51aabf5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Icosapent Ethyl
Dosage form: CAPSULE
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA209457
Marketing category: ANDA
Marketing start: 2020-11-04
Substance: ICOSAPENT ETHYL
Active strength: 1 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 1.

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
A209457-001	ICOSAPENT ETHYL	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB		2020-05-21
A209457-002	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.

Application-product, TE code table
Application-product	TE code
A209457-001	AB
A209457-002	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 · 60 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
2026-02-19 14:30 UTC	2026-02	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209457-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209457-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209457-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209457-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209457-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209457-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209457-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209457-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209457-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209457-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209457-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209457-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209457-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209457-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209457-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209457-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209457-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209457-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209457-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209457-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209457-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209457-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209457-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209457-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209457-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209457-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209457-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209457-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209457-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209457-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209457-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209457-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209457-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209457-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209457-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209457-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209457-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209457-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209457-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209457-001	AB	1	`1c564ffb4f44…`

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	1 g/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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e3d38d1d-fbe7-413d-849a-675e7dfa9b0a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f6766515-27b8-72de-2010-167151236ace	Product name	7	20251021
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0054-0508-23	Icosapent Ethyl	120 in 1 BOTTLE	CAPSULE	120		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-0508	ICOSAPENT ETHYL CAPSULE [HIKMA PHARMACEUTICALS USA INC.]	4	Current NDC, Legacy NDC, 1 package rows	20230314_e3d38d1d-fbe7-413d-849a-675e7dfa9b0a.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Icosapent Ethyl	ICOSAPENT ETHYL	Northstar Rx LLC	45f8bb41-bdb1-4afc-83ec-9dc69720ee9c	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209457 application number: ANDA209457
Icosapent Ethyl	ICOSAPENT ETHYL	Hikma Pharmaceuticals USA Inc.	e3d38d1d-fbe7-413d-849a-675e7dfa9b0a	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209457 application number: ANDA209457 ndc (package): 0054-0508-23 ndc (product): 0054-0508 ndc11 (package): 00054050823
Icosapent Ethyl	ICOSAPENT ETHYL	Bryant Ranch Prepack	07631e74-48e5-46ec-b8db-4b1bcf62d283	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209457 application number: ANDA209457
Icosapent Ethyl	ICOSAPENT ETHYL	Bryant Ranch Prepack	582638e5-9881-409d-a455-041b5ba6892a	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209457 application number: ANDA209457
Icosapent Ethyl	ICOSAPENT ETHYL	Bryant Ranch Prepack	0ee78f22-bed2-48f8-9be8-b8f6ceeeaeaf	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209457 application number: ANDA209457
Icosapent Ethyl	ICOSAPENT ETHYL	Bryant Ranch Prepack	f9c1a6a6-cda4-49ea-97e9-0d3cf5ab5d4c	2024-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209457 application number: ANDA209457

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	f9c1a6a6-cda4-49ea-97e9-0d3cf5ab5d4c	102
1304979	icosapent ethyl 1000 MG Oral Capsule	SCD	f9c1a6a6-cda4-49ea-97e9-0d3cf5ab5d4c	102
1304979	icosapent ethyl 1 GM Oral Capsule	SY	f9c1a6a6-cda4-49ea-97e9-0d3cf5ab5d4c	102
1304979	icosapent ethyl 1 GM Oral Capsule	PSN	0ee78f22-bed2-48f8-9be8-b8f6ceeeaeaf	100
1304979	icosapent ethyl 1 GM Oral Capsule	PSN	582638e5-9881-409d-a455-041b5ba6892a	100
1304979	icosapent ethyl 1000 MG Oral Capsule	SCD	0ee78f22-bed2-48f8-9be8-b8f6ceeeaeaf	100
1304979	icosapent ethyl 1000 MG Oral Capsule	SCD	582638e5-9881-409d-a455-041b5ba6892a	100
1304979	icosapent ethyl 1 GM Oral Capsule	SY	0ee78f22-bed2-48f8-9be8-b8f6ceeeaeaf	100
1304979	icosapent ethyl 1 GM Oral Capsule	SY	582638e5-9881-409d-a455-041b5ba6892a	100
1811180	icosapent ethyl 0.5 GM Oral Capsule	PSN	e3d38d1d-fbe7-413d-849a-675e7dfa9b0a	4
1304979	icosapent ethyl 1 GM Oral Capsule	PSN	e3d38d1d-fbe7-413d-849a-675e7dfa9b0a	4
1304979	icosapent ethyl 1000 MG Oral Capsule	SCD	e3d38d1d-fbe7-413d-849a-675e7dfa9b0a	4
1811180	icosapent ethyl 500 MG Oral Capsule	SCD	e3d38d1d-fbe7-413d-849a-675e7dfa9b0a	4
1811180	icosapent ethyl 0.5 GM Oral Capsule	SY	e3d38d1d-fbe7-413d-849a-675e7dfa9b0a	4
1304979	icosapent ethyl 1 GM Oral Capsule	SY	e3d38d1d-fbe7-413d-849a-675e7dfa9b0a	4
1304979	icosapent ethyl 1 GM Oral Capsule	PSN	07631e74-48e5-46ec-b8db-4b1bcf62d283	1
1304979	icosapent ethyl 1000 MG Oral Capsule	SCD	07631e74-48e5-46ec-b8db-4b1bcf62d283	1
1304979	icosapent ethyl 1 GM Oral Capsule	SY	07631e74-48e5-46ec-b8db-4b1bcf62d283	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-0508-23	00054050823	120 CAPSULE in 1 BOTTLE (0054-0508-23)	120 capsule	2020-11-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Icosapent Ethyl	Bryant Ranch Prepack	2026-08-10	HUMAN PRESCRIPTION DRUG LABEL	103
Icosapent Ethyl	Hikma Pharmaceuticals USA Inc.	2026-07-09	HUMAN PRESCRIPTION DRUG LABEL	5
Icosapent Ethyl	Bryant Ranch Prepack	2026-02-09	HUMAN PRESCRIPTION DRUG LABEL	1
Icosapent Ethyl	Bryant Ranch Prepack	2025-10-21	HUMAN PRESCRIPTION DRUG LABEL	100
Icosapent Ethyl	Bryant Ranch Prepack	2024-12-24	HUMAN PRESCRIPTION DRUG LABEL	100