OMEGA-3-ACID ETHYL ESTERS

Product NDC
0615-8550
11-digit product format
006158550
Labeler code
0615
Product ID
0615-8550_57a3c56b-8da3-4ec0-a45c-cd15f8173f43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OMEGA-3-ACID ETHYL ESTERS
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA210093
Marketing category
ANDA
Marketing start
2020-07-02
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
A210093-001OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210093-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-154b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-15c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-15cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210093-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2020-06-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210093-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210093-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210093-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210093-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210093-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210093-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210093-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210093-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210093-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210093-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210093-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210093-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210093-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210093-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210093-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210093-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210093-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210093-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210093-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210093-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A210093-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210093-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210093-001AB1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210093-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210093-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210093-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210093-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210093-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210093-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210093-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210093-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210093-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210093-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210093-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210093-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210093-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210093-001AB1a50c72e98297…

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
c293de7f-b4b6-461b-a0eb-470e5b84618dAvailable 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
0615-8550-39OMEGA-3-ACID ETHYL ESTERS30 in 1 BLISTER PACKCAPSULE, LIQUID FILLED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8550OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]1Current NDC, 1 package rows20241020_c293de7f-b4b6-461b-a0eb-470e5b84618d.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSREMEDYREPACK INC.c6b35b2d-5a65-4fc4-8a2c-af7b3aea3eee2026-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210093
application number: ANDA210093
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSA-S Medication Solutions6fea8860-3c63-435f-a5b0-4281364ebd092026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210093
application number: ANDA210093
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSA-S Medication Solutions4eef8b47-8185-4d93-9b2a-1200b953a6e32026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210093
application number: ANDA210093
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS52d4fc86-227a-4a74-9f42-50fd184714d82025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210093
application number: ANDA210093
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSEPIC PHARMA, LLC787f9929-ef31-42a7-a305-8ba343e396722025-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210093
application number: ANDA210093
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSNCS HealthCare of KY, LLC dba Vangard Labsc293de7f-b4b6-461b-a0eb-470e5b84618d2024-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210093
application number: ANDA210093
ndc (product): 0615-8550
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSBryant Ranch Prepackc8dc6c4a-ed19-4727-ba5a-35075f1ddddf2024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210093
application number: ANDA210093

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSNc293de7f-b4b6-461b-a0eb-470e5b84618d1
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCDc293de7f-b4b6-461b-a0eb-470e5b84618d1
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSYc293de7f-b4b6-461b-a0eb-470e5b84618d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0615-8550-390061585503930 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0615-8550-39) 2024-10-15NoNoCurrent