Home NDC 80725-420-12 Lovaza
Product NDC 80725-420
Requested package NDC 80725-420-12
11-digit product format 807250420
Labeler code 80725
Product ID 80725-420_bb196245-0938-40a1-bba1-c96dee9cf645
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OMEGA-3-ACID ETHYL ESTERS
Dosage form CAPSULE
Route ORAL
Labeler Waylis Therapeutics LLC
Application NDA021654
Marketing category NDA
Marketing start 2025-01-15
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 80725-420 80725-420-12 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 80725-420 80725-420-12 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021654-001 LOVAZA OMEGA-3-ACID ETHYL ESTERS 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021654-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021654-001 LOVAZA 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE / ORAL AB RLD, RS 2004-11-10 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80725-420-12 Lovaza 120 in 1 BOTTLE, PLASTIC CAPSULE 120 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80725-420 LOVAZA (OMEGA-3-ACID ETHYL ESTERS) CAPSULE [WAYLIS THERAPEUTICS LLC] 1 Current NDC, 1 package rows 20250209_21cfa4ce-0b05-47ed-b268-339eb1b83b75.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80725-420-12 80725042012 120 CAPSULE in 1 BOTTLE, PLASTIC (80725-420-12) 120 capsule 2025-01-15 No No Historical