ICOSAPENT ETHYL

Product NDC: 71335-2989
Requested package NDC: 71335-2989-2
11-digit product format: 713352989
Labeler code: 71335
Product ID: 71335-2989_9df091ac-075e-456c-9f09-faf11d1c4b0a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Icosapent ethyl
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA216811
Marketing category: ANDA
Marketing start: 2024-02-16
Substance: ICOSAPENT ETHYL
Active strength: 1 g/1
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A216811-001	ICOSAPENT ETHYL	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB		2023-12-07
A216811-002	ICOSAPENT ETHYL	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB		2024-02-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A216811-001	AB
A216811-002	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.

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	A216811-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216811-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2024-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216811-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216811-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2024-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216811-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216811-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2024-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216811-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216811-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2024-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216811-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216811-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2024-02-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216811-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216811-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2024-02-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216811-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216811-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2024-02-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216811-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216811-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2024-02-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216811-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216811-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2024-02-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216811-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216811-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2024-02-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216811-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216811-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2024-02-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216811-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216811-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2024-02-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216811-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216811-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2024-02-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216811-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216811-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2024-02-16	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216811-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-07	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216811-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2024-02-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216811-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-07	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216811-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216811-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2024-02-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216811-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216811-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216811-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216811-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216811-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216811-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216811-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216811-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216811-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216811-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216811-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216811-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216811-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216811-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216811-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216811-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216811-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216811-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216811-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216811-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216811-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216811-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216811-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216811-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216811-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216811-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216811-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216811-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216811-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216811-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216811-001	AB	1	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216811-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216811-002	AB	1	`a50c72e98297…`

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 · 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b4a1ca8a-2d22-4c54-9193-eab4e75ba7db	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-2989-1	ICOSAPENT ETHYL	30 in 1 BOTTLE	CAPSULE	30	1
71335-2989-2	ICOSAPENT ETHYL	60 in 1 BOTTLE	CAPSULE	60	1
71335-2989-3	ICOSAPENT ETHYL	120 in 1 BOTTLE	CAPSULE	120	1
71335-2989-4	ICOSAPENT ETHYL	90 in 1 BOTTLE	CAPSULE	90	1

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ICOSAPENT ETHYL	ICOSAPENT ETHYL	Camber Pharmaceuticals, Inc.	3e3498ab-f35e-4597-8556-89bf9fdd1406	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216811 application number: ANDA216811
ICOSAPENT ETHYL	ICOSAPENT ETHYL	XLCare Pharmaceuticals, Inc.	019cc0ac-0c2f-426d-996a-6d932f954443	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216811 application number: ANDA216811
ICOSAPENT ETHYL	ICOSAPENT ETHYL	Bryant Ranch Prepack	b4a1ca8a-2d22-4c54-9193-eab4e75ba7db	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216811 application number: ANDA216811 ndc (package): 71335-2989-2 ndc (product): 71335-2989 ndc11 (package): 71335298902
ICOSAPENT ETHYL	ICOSAPENT ETHYL	Northstar Rx LLC	b5b0b1ae-29ab-43a5-9e6d-24374d961399	2025-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216811 application number: ANDA216811

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	b4a1ca8a-2d22-4c54-9193-eab4e75ba7db	1
1304979	icosapent ethyl 1000 MG Oral Capsule	SCD	b4a1ca8a-2d22-4c54-9193-eab4e75ba7db	1
1304979	icosapent ethyl 1 GM Oral Capsule	SY	b4a1ca8a-2d22-4c54-9193-eab4e75ba7db	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-2989-2	71335298902	60 CAPSULE in 1 BOTTLE (71335-2989-2)	60 capsule	2026-02-04	No	No	Current