omega-3-acid ethyl esters

Product NDC: 64380-761
11-digit product format: 643800761
Labeler code: 64380
Product ID: 64380-761_8d39d714-db8f-4d90-90c7-ee249eb17de9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: omega-3-acid ethyl esters
Dosage form: CAPSULE
Route: ORAL
Labeler: Strides Pharma Science Limited
Application: ANDA203893
Marketing category: ANDA
Marketing start: 2019-01-18
Marketing end: 0000-00-00
Substance: OMEGA-3-ACID ETHYL ESTERS
Active strength: 900 mg/1
Pharmacologic classes: Fatty Acids, Omega-3 [CS],Omega-3 Fatty Acid [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203893-001	OMEGA-3-ACID ETHYL ESTERS	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB		2017-09-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203893-001	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 · 41 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	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203893-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2017-09-19	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A203893-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203893-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203893-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203893-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203893-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203893-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203893-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203893-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203893-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203893-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203893-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203893-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203893-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203893-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203893-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203893-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203893-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203893-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203893-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203893-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203893-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203893-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203893-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203893-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203893-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203893-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203893-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203893-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203893-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203893-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203893-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203893-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203893-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203893-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203893-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203893-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203893-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203893-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203893-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203893-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: omega-3-acid ethyl esters
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OMEGA-3-ACID ETHYL ESTERS	900 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
D87YGH4Z0Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
577208	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
9499c40e-6665-4fbf-914d-1a9931b93562	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ef9a935e-31b7-402c-a66c-716cdfe4f126	Product name	9	20241218
115c5bd2-98e1-4a98-8292-90803ca7e851	Product name	1	20220127

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
64380-761-01	omega-3-acid ethyl esters	10 in 1 BLISTER PACK	CAPSULE	10	7
64380-761-02	omega-3-acid ethyl esters	5 in 1 CARTON	CAPSULE	5	7
64380-761-11	omega-3-acid ethyl esters	120 in 1 BOTTLE	CAPSULE	120	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64380-761-11	EA - Each	64380-761	5782e2b0-f325-41e7-b616-2049828a152e	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64380-761	OMEGA-3-ACID ETHYL ESTERS CAPSULE [STRIDES PHARMA SCIENCE LIMITED]	6	Legacy NDC, 3 package rows	20211005_9499c40e-6665-4fbf-914d-1a9931b93562.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
omega-3-acid ethyl esters	OMEGA-3-ACID ETHYL ESTERS	Strides Pharma Science Limited	9499c40e-6665-4fbf-914d-1a9931b93562	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203893 application number: ANDA203893 ndc (product): 64380-761
omega-3-acid ethyl esters	OMEGA-3-ACID ETHYL ESTERS	American Health Packaging	294ee73f-849c-4c3d-a415-d66138c91f53	2025-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203893 application number: ANDA203893
Omega-3-acid ethyl esters	OMEGA-3-ACID ETHYL ESTERS	Par Pharmaceutical Inc.	b53f1c14-43da-4e05-8c80-a0a455dd41cf	2017-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203893 application number: ANDA203893

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D87YGH4Z0Q	OMEGA-3-ACID ETHYL ESTERS	308081-97-2	OMEGA-3-ACID ETHYL ESTERS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
577208	omega-3 acid ethyl esters 1 GM Oral Capsule	PSN	9499c40e-6665-4fbf-914d-1a9931b93562	7
577208	omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule	SCD	9499c40e-6665-4fbf-914d-1a9931b93562	7
577208	omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule	SY	9499c40e-6665-4fbf-914d-1a9931b93562	7
577208	omega-3 acid ethyl esters 1 GM Oral Capsule	PSN	294ee73f-849c-4c3d-a415-d66138c91f53	2
577208	omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule	SCD	294ee73f-849c-4c3d-a415-d66138c91f53	2
577208	omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule	SY	294ee73f-849c-4c3d-a415-d66138c91f53	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64380-761-01	64380076101	10 in 1 BLISTER PACK						Historical
64380-761-02	64380076102	5 BLISTER PACK in 1 CARTON (64380-761-02) > 10 CAPSULE in 1 BLISTER PACK (64380-761-01)	5 blister pack	2021-11-30	0000-00-00	No	No	Current
64380-761-11	64380076111	120 CAPSULE in 1 BOTTLE (64380-761-11)	120 capsule	2019-01-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
omega-3-acid ethyl esters	Strides Pharma Science Limited \| Onesource Specialty Pte. Limited	2026-05-26	HUMAN PRESCRIPTION DRUG LABEL	7
omega-3-acid ethyl esters	American Health Packaging	2025-04-29	HUMAN PRESCRIPTION DRUG LABEL	2