omega-3-acid ethyl esters

Product NDC
60687-846
Requested package NDC
60687-846-65
11-digit product format
606870846
Labeler code
60687
Product ID
60687-846_33eafe56-2385-cd60-e063-6294a90a5f4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omega-3-acid ethyl esters
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA203893
Marketing category
ANDA
Marketing start
2025-04-29
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
294ee73f-849c-4c3d-a415-d66138c91f53Available 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
60687-846-11omega-3-acid ethyl esters1 in 1 BLISTER PACKCAPSULE12
60687-846-65omega-3-acid ethyl esters50 in 1 CARTONCAPSULE502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-846-11EA - Each60687-846c3881ee3-a051-48f4-9ee6-33651646723d12025-05-14
60687-846-65EA - Each60687-846f31de195-e961-4639-8372-43aa9f51323f12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-846OMEGA-3-ACID ETHYL ESTERS CAPSULE [AMERICAN HEALTH PACKAGING]2Current NDC, 2 package rows20250430_294ee73f-849c-4c3d-a415-d66138c91f53.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
ndc (package): 60687-846-65
ndc (product): 60687-846
ndc11 (package): 60687084665
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSN294ee73f-849c-4c3d-a415-d66138c91f532
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCD294ee73f-849c-4c3d-a415-d66138c91f532
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSY294ee73f-849c-4c3d-a415-d66138c91f532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-846-656068708466550 BLISTER PACK in 1 CARTON (60687-846-65) / 1 CAPSULE in 1 BLISTER PACK (60687-846-11) 50 blister pack2025-04-29NoNoCurrent