Icosapent

Product NDC: 63629-9312
11-digit product format: 636299312
Labeler code: 63629
Product ID: 63629-9312_8988eb81-87de-4d83-8d5a-f9e0d2863618
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Icosapent Ethyl
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA209499
Marketing category: ANDA
Marketing start: 2021-06-21
Substance: ICOSAPENT ETHYL
Active strength: 1000 mg/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
A209499-001	ICOSAPENT ETHYL	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB		2020-08-07
A209499-002	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
A209499-001	AB
A209499-002	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	A209499-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209499-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209499-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209499-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209499-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209499-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209499-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209499-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209499-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209499-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209499-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209499-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209499-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209499-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209499-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-08-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209499-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209499-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-08-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209499-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209499-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-08-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209499-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209499-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-08-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209499-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209499-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-08-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209499-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209499-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-08-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209499-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209499-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-08-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209499-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209499-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-08-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209499-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-08-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209499-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-08-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209499-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-08-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209499-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-08-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209499-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-08-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209499-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-08-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209499-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-08-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209499-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-08-07	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209499-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-08-07	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209499-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209499-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-08-07	`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	A209499-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209499-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209499-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209499-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209499-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209499-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209499-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209499-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209499-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209499-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209499-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209499-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209499-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209499-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209499-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209499-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209499-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209499-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209499-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209499-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209499-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209499-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209499-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209499-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209499-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209499-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209499-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209499-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209499-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209499-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209499-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209499-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209499-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209499-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209499-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209499-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209499-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209499-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209499-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209499-001	AB	1	`1c564ffb4f44…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	Dr. Reddy's Laboratories, Inc.	cdcee03e-5df1-a8fc-7490-dfdc624ce6d6	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209499 application number: ANDA209499
Icosapent	ICOSAPENT ETHYL	Dr. Reddy's Laboratories, Inc.	1aca884c-c464-900d-ac06-33aee7118df8	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209499 application number: ANDA209499
Icosapent	ICOSAPENT ETHYL	Bryant Ranch Prepack	cc28828d-beab-45cc-a3b6-151c5fee3924	2024-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209499 application number: ANDA209499 ndc (product): 63629-9312

Additional Listing Data#

Finished product: Yes
Brand name base: Icosapent
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ICOSAPENT ETHYL	1000 mg/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
cc28828d-beab-45cc-a3b6-151c5fee3924	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	Strength	SPL version
63629-9312-1	Icosapent	120 in 1 BOTTLE	CAPSULE	120		102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-9312-1	EA - Each	63629-9312	19b93a2e-f5a8-49a6-8235-8ccd795c85c0	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-9312	ICOSAPENT (ICOSAPENT ETHYL) CAPSULE [BRYANT RANCH PREPACK]	102	Current NDC, Legacy NDC, 1 package rows	20240116_cc28828d-beab-45cc-a3b6-151c5fee3924.zip

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	cc28828d-beab-45cc-a3b6-151c5fee3924	102
1304979	icosapent ethyl 1000 MG Oral Capsule	SCD	cc28828d-beab-45cc-a3b6-151c5fee3924	102
1304979	icosapent ethyl 1 GM Oral Capsule	SY	cc28828d-beab-45cc-a3b6-151c5fee3924	102

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-9312-1	63629931201	120 CAPSULE in 1 BOTTLE (63629-9312-1)	120 capsule	2022-07-06	0000-00-00	No	No	Current