ICOSAPENT ETHYL

Product NDC: 71335-3148
Requested package NDC: 71335-3148-3
11-digit product format: 713353148
Labeler code: 71335
Product ID: 71335-3148_4d05c006-9a8b-4b54-b835-3ab2810e1dc1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: icosapent ethyl
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA217919
Marketing category: ANDA
Marketing start: 2023-12-22
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 43.

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
A217919-001	ICOSAPENT ETHYL	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB		2023-12-22
A217919-002	ICOSAPENT ETHYL	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB		2023-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217919-001	AB
A217919-002	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
2026-09-14 22:38:34	2026-08	A217919-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217919-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-12-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217919-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217919-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217919-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217919-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217919-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217919-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217919-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217919-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217919-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217919-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217919-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217919-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217919-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217919-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217919-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217919-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217919-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217919-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217919-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217919-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217919-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217919-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217919-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217919-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217919-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217919-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217919-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217919-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217919-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217919-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-12-22	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217919-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-22	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217919-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217919-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-22	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217919-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-12-22	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217919-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-12-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217919-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-12-22	`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	A217919-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217919-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217919-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217919-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217919-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217919-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217919-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217919-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217919-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217919-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217919-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217919-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217919-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217919-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217919-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217919-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217919-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217919-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217919-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217919-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217919-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217919-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217919-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217919-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217919-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217919-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217919-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217919-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217919-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217919-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217919-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217919-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217919-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217919-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217919-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217919-002	AB	1	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217919-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217919-002	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
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
b6e361cc-c314-4402-9361-2d977788e93c	Available on FDA.report

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	Bryant Ranch Prepack	b6e361cc-c314-4402-9361-2d977788e93c	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217919 application number: ANDA217919 ndc (package): 71335-3148-3 ndc (product): 71335-3148 ndc11 (package): 71335314803
ICOSAPENT ETHYL	ICOSAPENT ETHYL	EPIC PHARMA, LLC	30574162-0e84-4352-b7fa-42fc20115d68	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217919 application number: ANDA217919
ICOSAPENT ETHYL	ICOSAPENT ETHYL	EPIC PHARMA, LLC	6db749b9-c817-41cd-909f-dd60a90c9f73	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217919 application number: ANDA217919

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-3148-3	71335314803	120 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-3148-3)	2026-06-18	No	No	Current