Omega-3-acid ethyl esters

Product NDC
70518-4744
11-digit product format
705184744
Labeler code
70518
Product ID
70518-4744_5a935c7a-4dd7-0d80-e063-6294a90a350f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omega-3-acid ethyl esters
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207420
Marketing category
ANDA
Marketing start
2026-09-02
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A207420-001OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207420-001AB

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-2584e616aacf4f…
2026-08-18 06:07:402026-07A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-253f01610625f2…
2019-09-15 20:21 UTC2019-09A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207420-001OMEGA-3-ACID ETHYL ESTERS1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE / ORALAB2019-02-25f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A207420-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A207420-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207420-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207420-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207420-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207420-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207420-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207420-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207420-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207420-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207420-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207420-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207420-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207420-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207420-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207420-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207420-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207420-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207420-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207420-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207420-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207420-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207420-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A207420-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207420-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207420-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207420-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A207420-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207420-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207420-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207420-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207420-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207420-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207420-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207420-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207420-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207420-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207420-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207420-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207420-001AB1f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
9e041905-40a7-4d5b-af1c-6c544e0748b9Available on FDA.report

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSREMEDYREPACK INC.9e041905-40a7-4d5b-af1c-6c544e0748b92026-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207420
application number: ANDA207420
ndc (product): 70518-4744
Omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSCamber Pharmaceuticals, Inc.0d842966-26bc-4521-b401-635a836180122026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207420
application number: ANDA207420
Omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSXLCare Pharmaceuticals, Inc.18947318-31b4-42fb-83be-8f1bfe732e952026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207420
application number: ANDA207420
Omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSBryant Ranch Prepack7d75287f-6f09-43b0-9b38-150685236d472024-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207420
application number: ANDA207420
Omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSA-S Medication Solutions730e47e0-d2eb-46c5-8be7-1d0cd5b4a6fa2024-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207420
application number: ANDA207420
Omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSA-S Medication Solutionsb11807f8-4301-4f91-8a7a-53226f945c492024-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207420
application number: ANDA207420
Omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSBryant Ranch Prepack034045d6-5308-4701-b97b-8873e053ec172023-10-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207420
application number: ANDA207420
Omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSA-S Medication Solutions990a3e8a-8642-43d7-ace3-0dd7c48ff3e92023-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207420
application number: ANDA207420

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4744-070518474400180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (70518-4744-0) 2026-09-02NoNoCurrent