Omega-3-acid ethyl esters

Product NDC
0254-3010
11-digit product format
002543010
Labeler code
0254
Product ID
0254-3010_9b349968-03b7-4a4f-ab40-976570f5e398
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omega-3-acid ethyl esters
Dosage form
CAPSULE
Route
ORAL
Labeler
Par Pharmaceutical Inc.
Application
ANDA203893
Marketing category
ANDA
Marketing start
2017-09-19
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
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
A203893-001OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203893-001AB

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 UTC2026-02A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-193f01610625f2…
2019-09-15 20:21 UTC2019-09A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203893-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2017-09-19cb3db0bc1861…

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 UTC2026-02A203893-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203893-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203893-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203893-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203893-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203893-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203893-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203893-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203893-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203893-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203893-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203893-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203893-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203893-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203893-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203893-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203893-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203893-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203893-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203893-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203893-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A203893-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203893-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203893-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203893-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A203893-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203893-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203893-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203893-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203893-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203893-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203893-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203893-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203893-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203893-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203893-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203893-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203893-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203893-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203893-001AB1cb3db0bc1861…

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 ESTERS900 mg/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
b53f1c14-43da-4e05-8c80-a0a455dd41cfAvailable 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
0254-3010-08Omega-3-acid ethyl esters120 in 1 BOTTLECAPSULE1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0254-3010-08EA - Each0254-3010d53c8c3a-4a0b-4139-b263-9018711df52412018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0254-3010OMEGA-3-ACID ETHYL ESTERS CAPSULE [PAR PHARMACEUTICAL INC.]1Current NDC, Legacy NDC, 1 package rows20170925_b53f1c14-43da-4e05-8c80-a0a455dd41cf.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSStrides Pharma Science Limited9499c40e-6665-4fbf-914d-1a9931b935622026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203893
application number: ANDA203893
omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSAmerican Health Packaging294ee73f-849c-4c3d-a415-d66138c91f532025-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203893
application number: ANDA203893
Omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSPar Pharmaceutical Inc.b53f1c14-43da-4e05-8c80-a0a455dd41cf2017-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203893
application number: ANDA203893
ndc (product): 0254-3010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSNb53f1c14-43da-4e05-8c80-a0a455dd41cf1
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCDb53f1c14-43da-4e05-8c80-a0a455dd41cf1
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSYb53f1c14-43da-4e05-8c80-a0a455dd41cf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0254-3010-0800254301008120 CAPSULE in 1 BOTTLE (0254-3010-08) 120 capsule2017-09-190000-00-00NoNoCurrent