Omega-3-Acid Ethyl Esters

Product NDC
51407-763
11-digit product format
514070763
Labeler code
51407
Product ID
51407-763_4ece33da-8d1d-0266-e063-6394a90ad29e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omega-3-Acid Ethyl Esters
Dosage form
CAPSULE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA091028
Marketing category
ANDA
Marketing start
2014-04-07
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091028-001OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091028-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-073f01610625f2…
2019-09-15 20:21 UTC2019-09A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091028-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2014-04-07cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091028-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091028-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091028-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091028-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091028-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091028-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091028-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091028-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091028-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091028-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091028-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091028-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091028-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091028-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091028-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091028-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091028-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091028-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091028-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091028-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091028-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A091028-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091028-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091028-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091028-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091028-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091028-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091028-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091028-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091028-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091028-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091028-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091028-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091028-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091028-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091028-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091028-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091028-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091028-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091028-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Omega-3-Acid Ethyl Esters
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEGA-3-ACID ETHYL ESTERS1 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
D87YGH4Z0QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
577208Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
11d744aa-cc06-1206-e063-6294a90a49c9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-763-12Omega-3-Acid Ethyl Esters120 in 1 BOTTLE, PLASTICCAPSULE1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-763-12EA - Each51407-763a6fc4348-f9c6-44ab-8437-d381e279095f12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-763OMEGA-3-ACID ETHYL ESTERS CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2Current NDC, 1 package rows20250411_11d744aa-cc06-1206-e063-6294a90a49c9.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Omega-3-Acid Ethyl EstersOMEGA-3-ACID ETHYL ESTERSGolden State Medical Supply, Inc.11d744aa-cc06-1206-e063-6294a90a49c92026-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091028
application number: ANDA091028
ndc (product): 51407-763
Omega-3-Acid Ethyl EstersOMEGA-3-ACID ETHYL ESTERSKD Pharma USA, Inc.d1fd2a28-befb-4a09-b516-0c01bc4c8c6c2025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091028
application number: ANDA091028

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSN11d744aa-cc06-1206-e063-6294a90a49c93
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCD11d744aa-cc06-1206-e063-6294a90a49c93
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSY11d744aa-cc06-1206-e063-6294a90a49c93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-763-1251407076312120 CAPSULE in 1 BOTTLE, PLASTIC (51407-763-12) 120 capsule2023-12-19NoNoCurrent