Omega-3-Acid Ethyl Esters

Product NDC
72998-851
11-digit product format
729980851
Labeler code
72998
Product ID
72998-851_1ef0517f-68e3-4a99-97ff-b367aad55ff3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omega-3-Acid Ethyl Esters
Dosage form
CAPSULE
Route
ORAL
Labeler
KD Pharma USA, Inc.
Application
ANDA091028
Marketing category
ANDA
Marketing start
2024-02-01
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
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 · 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
2026-12-31

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
d1fd2a28-befb-4a09-b516-0c01bc4c8c6cAvailable 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
72998-851-12Omega-3-Acid Ethyl Esters120 in 1 BOTTLE, PLASTICCAPSULE1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72998-851-12EA - Each72998-851a9518ec2-6cbe-4590-a931-6435f0d4e05c12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72998-851OMEGA-3-ACID ETHYL ESTERS CAPSULE [KD PHARMA USA, INC.]2Current NDC, 1 package rows20250213_d1fd2a28-befb-4a09-b516-0c01bc4c8c6c.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
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
ndc (product): 72998-851

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
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSNd1fd2a28-befb-4a09-b516-0c01bc4c8c6c2
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCDd1fd2a28-befb-4a09-b516-0c01bc4c8c6c2
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSYd1fd2a28-befb-4a09-b516-0c01bc4c8c6c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72998-851-1272998085112120 CAPSULE in 1 BOTTLE, PLASTIC (72998-851-12) 120 capsule2024-02-01NoNoCurrent