Icosapent

Product NDC: 43598-267
Requested package NDC: 43598-267-04
11-digit product format: 435980267
Labeler code: 43598
Product ID: 43598-267_d6afc522-23f4-025c-df81-109460653b4d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Icosapent Ethyl
Dosage form: CAPSULE
Route: ORAL
Labeler: Dr. Reddy's Laboratories, Inc.
Application: ANDA209499
Marketing category: ANDA
Marketing start: 2021-06-21
Marketing end: 2027-09-30
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Icosapent

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
1aca884c-c464-900d-ac06-33aee7118df8	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43598-267-04	Icosapent	120 in 1 BOTTLE	CAPSULE	120		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-267-04	EA - Each	43598-267	eb10fb4d-f4f1-40e2-abd2-e0022ab5619f	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-267	ICOSAPENT (ICOSAPENT ETHYL) CAPSULE [DR. REDDY'S LABORATORIES, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20210928_1aca884c-c464-900d-ac06-33aee7118df8.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 · 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 ndc (package): 43598-267-04 ndc (product): 43598-267 ndc11 (package): 43598026704
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

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
1304979	icosapent ethyl 1 GM Oral Capsule	PSN	1aca884c-c464-900d-ac06-33aee7118df8	3
1304979	icosapent ethyl 1000 MG Oral Capsule	SCD	1aca884c-c464-900d-ac06-33aee7118df8	3
1304979	icosapent ethyl 1 GM Oral Capsule	SY	1aca884c-c464-900d-ac06-33aee7118df8	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43598-267-04	43598026704	120 CAPSULE in 1 BOTTLE (43598-267-04)	120 capsule	2021-06-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Icosapent	Bryant Ranch Prepack	2026-08-10	HUMAN PRESCRIPTION DRUG LABEL	103
Icosapent	Dr. Reddy's Laboratories, Inc.	2026-07-22	HUMAN PRESCRIPTION DRUG LABEL	5
Icosapent	AvKARE	2024-01-24	HUMAN PRESCRIPTION DRUG LABEL	1