Omega-3-acid ethyl esters

Product NDC: 31722-936
11-digit product format: 317220936
Labeler code: 31722
Product ID: 31722-936_09d3e919-e5e3-4ed5-b23c-5e91f4a95e6c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omega-3-acid ethyl esters
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA207420
Marketing category: ANDA
Marketing start: 2019-02-25
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: 2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207420-001	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		2019-02-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207420-001	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	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207420-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-02-25	`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	A207420-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207420-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207420-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207420-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207420-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207420-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207420-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207420-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207420-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207420-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207420-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207420-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207420-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207420-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207420-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207420-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207420-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207420-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207420-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207420-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207420-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207420-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207420-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207420-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207420-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207420-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207420-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207420-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207420-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207420-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207420-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207420-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207420-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207420-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207420-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207420-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207420-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207420-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207420-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207420-001	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	1 g/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
0d842966-26bc-4521-b401-635a83618012	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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
31722-936-05	Omega-3-acid ethyl esters	500 in 1 BOTTLE	CAPSULE, LIQUID FILLED	500		4
31722-936-12	Omega-3-acid ethyl esters	120 in 1 BOTTLE	CAPSULE, LIQUID FILLED	120		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-936-12	EA - Each	31722-936	c778bdcd-131b-4611-80f6-577db51b577e	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-936	OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [CAMBER PHARMACEUTICALS, INC.]	3	Current NDC, Legacy NDC, 2 package rows	20210720_0d842966-26bc-4521-b401-635a83618012.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 · 7 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	Camber Pharmaceuticals, Inc.	0d842966-26bc-4521-b401-635a83618012	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207420 application number: ANDA207420 ndc (product): 31722-936
Omega-3-acid ethyl esters	OMEGA-3-ACID ETHYL ESTERS	XLCare Pharmaceuticals, Inc.	18947318-31b4-42fb-83be-8f1bfe732e95	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207420 application number: ANDA207420
Omega-3-acid ethyl esters	OMEGA-3-ACID ETHYL ESTERS	Bryant Ranch Prepack	7d75287f-6f09-43b0-9b38-150685236d47	2024-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207420 application number: ANDA207420
Omega-3-acid ethyl esters	OMEGA-3-ACID ETHYL ESTERS	A-S Medication Solutions	730e47e0-d2eb-46c5-8be7-1d0cd5b4a6fa	2024-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207420 application number: ANDA207420
Omega-3-acid ethyl esters	OMEGA-3-ACID ETHYL ESTERS	A-S Medication Solutions	b11807f8-4301-4f91-8a7a-53226f945c49	2024-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207420 application number: ANDA207420
Omega-3-acid ethyl esters	OMEGA-3-ACID ETHYL ESTERS	Bryant Ranch Prepack	034045d6-5308-4701-b97b-8873e053ec17	2023-10-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207420 application number: ANDA207420
Omega-3-acid ethyl esters	OMEGA-3-ACID ETHYL ESTERS	A-S Medication Solutions	990a3e8a-8642-43d7-ace3-0dd7c48ff3e9	2023-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207420 application number: ANDA207420

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	7d75287f-6f09-43b0-9b38-150685236d47	104
577208	omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule	SCD	7d75287f-6f09-43b0-9b38-150685236d47	104
577208	omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule	SY	7d75287f-6f09-43b0-9b38-150685236d47	104
577208	omega-3 acid ethyl esters 1 GM Oral Capsule	PSN	034045d6-5308-4701-b97b-8873e053ec17	100
577208	omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule	SCD	034045d6-5308-4701-b97b-8873e053ec17	100
577208	omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule	SY	034045d6-5308-4701-b97b-8873e053ec17	100
577208	omega-3 acid ethyl esters 1 GM Oral Capsule	PSN	990a3e8a-8642-43d7-ace3-0dd7c48ff3e9	6
577208	omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule	SCD	990a3e8a-8642-43d7-ace3-0dd7c48ff3e9	6
577208	omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule	SY	990a3e8a-8642-43d7-ace3-0dd7c48ff3e9	6
577208	omega-3 acid ethyl esters 1 GM Oral Capsule	PSN	0d842966-26bc-4521-b401-635a83618012	4
577208	omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule	SCD	0d842966-26bc-4521-b401-635a83618012	4
577208	omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule	SY	0d842966-26bc-4521-b401-635a83618012	4
577208	omega-3 acid ethyl esters 1 GM Oral Capsule	PSN	730e47e0-d2eb-46c5-8be7-1d0cd5b4a6fa	2
577208	omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule	SCD	730e47e0-d2eb-46c5-8be7-1d0cd5b4a6fa	2
577208	omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule	SY	730e47e0-d2eb-46c5-8be7-1d0cd5b4a6fa	2
577208	omega-3 acid ethyl esters 1 GM Oral Capsule	PSN	b11807f8-4301-4f91-8a7a-53226f945c49	1
577208	omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule	SCD	b11807f8-4301-4f91-8a7a-53226f945c49	1
577208	omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule	SY	b11807f8-4301-4f91-8a7a-53226f945c49	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
31722-936-05	31722093605	500 CAPSULE, LIQUID FILLED in 1 BOTTLE (31722-936-05)	2019-02-25	0000-00-00	No	No	Current
31722-936-12	31722093612	120 CAPSULE, LIQUID FILLED in 1 BOTTLE (31722-936-12)	2019-02-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omega-3-acid ethyl esters	Camber Pharmaceuticals, Inc. \| Ascent Pharmaceuticals, Inc.	2026-04-30	HUMAN PRESCRIPTION DRUG LABEL	4
Omega-3-acid ethyl esters	Bryant Ranch Prepack	2024-12-27	HUMAN PRESCRIPTION DRUG LABEL	104
Omega-3-acid ethyl esters	A-S Medication Solutions	2024-02-18	HUMAN PRESCRIPTION DRUG LABEL	2
Omega-3-acid ethyl esters	A-S Medication Solutions	2024-01-21	HUMAN PRESCRIPTION DRUG LABEL	1
Omega-3-acid ethyl esters	Bryant Ranch Prepack	2023-10-06	HUMAN PRESCRIPTION DRUG LABEL	100
Omega-3-acid ethyl esters	A-S Medication Solutions	2023-05-22	HUMAN PRESCRIPTION DRUG LABEL	6