Omega-3-acid ethyl esters

Product NDC: 60505-3170
Requested package NDC: 60505-3170-3
11-digit product format: 605053170
Labeler code: 60505
Product ID: 60505-3170_b6e21953-3718-143a-4134-31b2d4f19e9c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omega-3-acid ethyl esters
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA090973
Marketing category: ANDA
Marketing start: 2014-09-30
Marketing end: 0000-00-00
Substance: OMEGA-3-ACID ETHYL ESTERS
Active strength: 1 g/1
Pharmacologic classes: Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	60505-3170	60505-3170-3	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60505-3170	60505-3170-3	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60505-3170	60505-3170-3	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A090973-001	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			2014-09-30

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	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090973-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2014-09-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090973-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090973-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090973-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090973-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090973-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090973-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090973-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090973-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090973-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090973-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090973-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090973-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090973-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090973-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090973-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090973-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090973-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090973-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090973-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090973-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090973-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090973-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090973-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090973-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090973-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090973-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090973-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090973-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090973-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090973-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090973-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090973-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090973-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090973-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090973-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090973-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090973-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090973-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090973-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090973-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6e3c022f-0786-43f1-8857-edff89d5153f	Product name	1	20260309
16a2c1cd-ae95-d910-f03d-7e06b11dd243	Product name	5	20260202
86fffa7b-d382-4771-a253-25cccb64b590	Product name	3	20251124
c599c4a0-705d-4ebb-ab1f-977af038f96a	Product name	1	20251124
653485de-0601-41e4-82db-7a60bb223e27	Product name	1	20251024
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
cf050ccd-1144-f76a-e00d-e5698d8597d4	Product name	6	20250625
ef9a935e-31b7-402c-a66c-716cdfe4f126	Product name	9	20241218
23fb3cda-2b50-f3d3-ebde-f542350bd77b	Product name	4	20240828
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8	Product name	2	20240805
efd58652-cb8f-4018-91ca-4b0eb2ff729f	Product name	7	20240226
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
081b54f0-4545-48b6-b854-03e1401f09ea	Product name	1	20230112
115c5bd2-98e1-4a98-8292-90803ca7e851	Product name	1	20220127
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62	Product name	3	20210309
91c62db0-0295-c81c-d10a-0856c259edd6	Product name	2	20200428
d32bc2b8-0bb7-2216-87aa-24639646e202	Product name	3	20190619
e2dae634-14ed-febf-08ee-93196433b5b7	Product name	9	20190614
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
aead65a2-216e-4ff8-a178-44aab77c24ed	Product name	1	20180531
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d206bb34-ea65-399d-70d9-834f22dc2c18	Product name	3	20170724
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
e7e58cd3-cacb-49df-8d34-1ee335614abb	Product name	1	20150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
0a5e5249-329b-0cff-e714-77159f193a87	Product name	1	20140508
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
d394f843-7479-dc48-dbd3-232266c5548c	Product name	1	20140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60505-3170-7	Omega-3 Well Pack	120 in 1 BOTTLE	CAPSULE, LIQUID FILLED	1	1 g	2
60505-3170-7	Omega-3 Well Pack	1 in 1 BOTTLE	CAPSULE, LIQUID FILLED	1	1 g	1
60505-3170-7	Omega-3 Rx Complete	1 in 1 BOTTLE	CAPSULE, LIQUID FILLED	1	1 g	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-3170-7	EA - Each	60505-3170	d2fb1b7a-3ac8-4d8e-9bb4-bfb8124fac78	1	2015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OMEGA-3-ACID ETHYL ESTERS	ACTIVE INGREDIENT	D87YGH4Z0Q	OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]	2
OMEGA-3 FATTY ACIDS	ACTIVE MOIETY	71M78END5S	OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]	2
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]	2
Ammonia	INACTIVE INGREDIENT	5138Q19F1X	OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]	2
OMEGA-3-ACID ETHYL ESTERS	ACTIVE INGREDIENT	D87YGH4Z0Q	OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]	1
OMEGA-3-ACID ETHYL ESTERS	ACTIVE INGREDIENT	D87YGH4Z0Q	OMEGA-3 WELL PACK KIT [TMIG, INC.]	1
VITAMIN D	ACTIVE INGREDIENT	9VU1KI44GP	OMEGA-3 WELL PACK KIT [TMIG, INC.]	1
OMEGA-3 FATTY ACIDS	ACTIVE MOIETY	71M78END5S	OMEGA-3 WELL PACK KIT [TMIG, INC.]	1
OMEGA-3 FATTY ACIDS	ACTIVE MOIETY	71M78END5S	OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]	1
VITAMIN D	ACTIVE MOIETY	9VU1KI44GP	OMEGA-3 WELL PACK KIT [TMIG, INC.]	1
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]	1
ALPHA-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	OMEGA-3 WELL PACK KIT [TMIG, INC.]	1
Ammonia	INACTIVE INGREDIENT	5138Q19F1X	OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEGA-3 WELL PACK KIT [TMIG, INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	OMEGA-3 WELL PACK KIT [TMIG, INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEGA-3 WELL PACK KIT [TMIG, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	OMEGA-3 WELL PACK KIT [TMIG, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEGA-3 WELL PACK KIT [TMIG, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEGA-3 WELL PACK KIT [TMIG, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OMEGA-3 WELL PACK KIT [TMIG, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEGA-3 WELL PACK KIT [TMIG, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	OMEGA-3 WELL PACK KIT [TMIG, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-3170	OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.]	15	Legacy NDC	20250523_1dd5cda1-6077-f8bc-69f3-e8685a49f39d.zip
60505-3170	OMEGA-3 WELL PACK KIT [CLOVERLEAF PHARMA LLC]	2	Legacy NDC	20200122_9caa9c29-b439-4a5c-e053-2a95a90af7fd.zip
60505-3170	OMEGA-3 RX COMPLETE KIT [TMIG, INC.]	1	Legacy NDC	20190121_ff4a8e34-360b-4a9d-b8d2-d3cf447b6338.zip
60505-3170	OMEGA-3 WELL PACK KIT [TMIG, INC.]	1	Legacy NDC	20150902_1eb20ef6-7a56-5b3e-e054-00144ff88e88.zip

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	e57f57fe-1af6-468a-9e72-d3144d63aecf	100
577208	omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule	SCD	e57f57fe-1af6-468a-9e72-d3144d63aecf	100
577208	omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule	SY	e57f57fe-1af6-468a-9e72-d3144d63aecf	100
577208	omega-3 acid ethyl esters 1 GM Oral Capsule	PSN	2bfadd2a-79e8-4fda-ae2c-134106c0feba	6
577208	omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule	SCD	2bfadd2a-79e8-4fda-ae2c-134106c0feba	6
577208	omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule	SY	2bfadd2a-79e8-4fda-ae2c-134106c0feba	6
577208	omega-3 acid ethyl esters 1 GM Oral Capsule	PSN	9caa9c29-b439-4a5c-e053-2a95a90af7fd	2
577208	omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule	SCD	9caa9c29-b439-4a5c-e053-2a95a90af7fd	2
577208	omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule	SY	9caa9c29-b439-4a5c-e053-2a95a90af7fd	2
577208	omega-3 acid ethyl esters 1 GM Oral Capsule	PSN	1eb20ef6-7a56-5b3e-e054-00144ff88e88	1
577208	omega-3 acid ethyl esters 1 GM Oral Capsule	PSN	ff4a8e34-360b-4a9d-b8d2-d3cf447b6338	1
577208	omega-3 acid ethyl esters 1 GM Oral Capsule	PSN	6735c25d-0f09-4959-b8ee-3650ef1b3a52	1
577208	omega-3 acid ethyl esters 1 GM Oral Capsule	PSN	8f274c0a-3072-8233-e053-2a95a90aa0bc	1
577208	omega-3 acid ethyl esters 1 GM Oral Capsule	PSN	8f2795af-acfb-24e5-e053-2995a90a58d1	1
577208	omega-3 acid ethyl esters 1 GM Oral Capsule	PSN	8f2833dc-a3fe-ca8e-e053-2995a90ad88e	1
577208	omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule	SCD	ff4a8e34-360b-4a9d-b8d2-d3cf447b6338	1
577208	omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule	SCD	8f2833dc-a3fe-ca8e-e053-2995a90ad88e	1
577208	omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule	SCD	8f2795af-acfb-24e5-e053-2995a90a58d1	1
577208	omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule	SCD	8f274c0a-3072-8233-e053-2a95a90aa0bc	1
577208	omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule	SCD	6735c25d-0f09-4959-b8ee-3650ef1b3a52	1
577208	omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule	SCD	1eb20ef6-7a56-5b3e-e054-00144ff88e88	1
577208	omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule	SY	8f2833dc-a3fe-ca8e-e053-2995a90ad88e	1
577208	omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule	SY	8f2795af-acfb-24e5-e053-2995a90a58d1	1
577208	omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule	SY	8f274c0a-3072-8233-e053-2a95a90aa0bc	1
577208	omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule	SY	6735c25d-0f09-4959-b8ee-3650ef1b3a52	1
577208	omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule	SY	ff4a8e34-360b-4a9d-b8d2-d3cf447b6338	1
577208	omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule	SY	1eb20ef6-7a56-5b3e-e054-00144ff88e88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-3170-3	60505317003	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (60505-3170-3)	2014-09-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omega-3-acid ethyl esters	Apotex Corp. \| Apotex Inc.	2025-08-07	HUMAN PRESCRIPTION DRUG LABEL	16
Omega-3-acid ethyl esters	Major Pharmaceuticals	2024-06-17	HUMAN PRESCRIPTION DRUG LABEL	4
Omega-3-acid ethyl esters	American Health Packaging	2024-05-10	HUMAN PRESCRIPTION DRUG LABEL	7
Omega-3-acid ethyl esters	Bryant Ranch Prepack	2023-09-19	HUMAN PRESCRIPTION DRUG LABEL	100
Omega-3-acid ethyl esters	Bryant Ranch Prepack	2022-06-22	HUMAN PRESCRIPTION DRUG LABEL	100
Omega-3-acid ethyl esters	A-S Medication Solutions	2021-04-16	HUMAN PRESCRIPTION DRUG LABEL	6
Omega-3-acid ethyl esters	Quality Care Products, LLC	2021-04-15	HUMAN PRESCRIPTION DRUG LABEL	2
Omega-3-acid ethyl esters	REMEDYREPACK INC.	2021-03-01	HUMAN PRESCRIPTION DRUG LABEL	5
Omega-3-acid ethyl esters	A-S Medication Solutions	2021-03-01	HUMAN PRESCRIPTION DRUG LABEL	1
Omega-3, D-3 Wellness Pack	Cloverleaf Pharma LLC \| EPM Packaging \| Apotex Inc. \| Accucaps Industries Limited	2020-01-01	HUMAN PRESCRIPTION DRUG LABEL	2
OMEGA-3-ACID ETHYL ESTERS	Direct_Rx	2019-08-02	HUMAN PRESCRIPTION DRUG LABEL	1
OMEGA-3-ACID ETHYL ESTERS	Direct_Rx	2019-08-02	HUMAN PRESCRIPTION DRUG LABEL	1
OMEGA-3-ACID ETHYL ESTERS	Direct_Rx	2019-08-02	HUMAN PRESCRIPTION DRUG LABEL	1
Omega-3 Rx Complete	TMIG, Inc. \| EPM Packaging \| Apotex Inc.	2019-01-17	HUMAN PRESCRIPTION DRUG LABEL	1
Omega-3, D-3 Wellness Pack	TMIG, Inc. \| EPM Packaging \| Apotex Inc.	2015-09-01	HUMAN PRESCRIPTION DRUG LABEL	1