ICOSAPENT ETHYL capsules, for oral use

Manufacturer: Softgel Healthcare Private Limited
Effective date: 2026-07-09
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: daily-update
Hydrated at: 2026-07-17 21:46:03

Label at a glance#

Producticosapent ethyl

Active ingredientICOSAPENT ETHYL

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 35916-1738-1

Icosapent Ethyl Capsules

0.5 gram

240 capsules

Rx only

NDC 35916-1592-1

Icosapent Ethyl Capsules

1 gram

240 capsules

Rx only

DailyMed Product Concepts#

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

icosapent ethyl
ICOSAPENT
.ALPHA.-TOCOPHEROL
GELATIN
GLYCERIN
WATER
TITANIUM DIOXIDE
SHELLAC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
35916-1738	35916-1738-1
35916-1592	35916-1592-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ICOSAPENT ETHYL	6GC8A4PAYH	ACTIB
.ALPHA.-TOCOPHEROL	H4N855PNZ1	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
SHELLAC	46N107B71O	IACT
ICOSAPENT ETHYL	6GC8A4PAYH	ACTIB
.ALPHA.-TOCOPHEROL	H4N855PNZ1	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
SHELLAC	46N107B71O	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
1	2024-10-25	full-release	2026-05-31 21:26:46

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
A217656-001	ICOSAPENT ETHYL	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB		2023-04-20
A217656-002	ICOSAPENT ETHYL	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB		2023-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217656-001	AB
A217656-002	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 · 48 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
2026-09-14 22:38:34	2026-08	A217656-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217656-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-04-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217656-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217656-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-04-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217656-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217656-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217656-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217656-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217656-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217656-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217656-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217656-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217656-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217656-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217656-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217656-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217656-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217656-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217656-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217656-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217656-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-04-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217656-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217656-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-04-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217656-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217656-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-04-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217656-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217656-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-04-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217656-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217656-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-04-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217656-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-04-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217656-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-04-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217656-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-04-20	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217656-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-04-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217656-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-04-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217656-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-04-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217656-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-04-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217656-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-04-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217656-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-04-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217656-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-04-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217656-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2023-04-20	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217656-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217656-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217656-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217656-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217656-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217656-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217656-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217656-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217656-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217656-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217656-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217656-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217656-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217656-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217656-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217656-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217656-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217656-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217656-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217656-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217656-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217656-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217656-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217656-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217656-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217656-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217656-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217656-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217656-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217656-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217656-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217656-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217656-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217656-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217656-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217656-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217656-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217656-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217656-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217656-002	AB	1	`a72a2bbeb626…`

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	Softgel Healthcare Private Limited	6f5838cd-4d17-401d-8e2a-652d0e73c1e9	2026-07-09		Exact identifier ndc (package): 35916-1592-1 ndc (package): 35916-1738-1 ndc (product): 35916-1738 ndc (product): 35916-1592 ndc11 (package): 35916173801 ndc11 (package): 35916159201 spl id: dc378404-3406-4fc0-829d-cc8273af1ca0 spl set id: 6f5838cd-4d17-401d-8e2a-652d0e73c1e9

Reported adverse events (FAERS/openFDA)#

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