Home NDC 54766-907 BRISDELLE
Product NDC 54766-907
11-digit product format 547660907
Labeler code 54766
Product ID 54766-907_e190f18a-ef9d-7e9e-e053-2995a90af934
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name paroxetine
Dosage form CAPSULE
Route ORAL
Labeler Sebela Pharmaceuticals Inc.
Application NDA204516
Marketing category NDA
Marketing start 2017-05-23
Marketing end 2023-01-31
Substance PAROXETINE MESYLATE
Active strength 8 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 54766-907-53 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 54766-907-53 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 54766-907-53 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 54766-907-53 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 54766-907-53 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 54766-907-53 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 54766-907-53 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 54766-907-53 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 54766-907-53 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 54766-907-53 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 54766-907-53 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 54766-907-53 557ba5c1ecfa…9c80585c8c6e…
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 N204516-001 BRISDELLE PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N204516-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N204516-001 8946251 2026-08-04 U-904 Drug substance, Drug product 2015-02-09 N204516-001 9393237 2026-08-04 U-904 2016-08-11 N204516-001 8658663 2029-04-06 U-904 Drug substance, Drug product 2014-03-04
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 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Patent history page 1 of 5 · 162 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N204516-001 8946251 2026-08-04 U-904 Drug substance, Drug product 2015-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204516-001 9393237 2026-08-04 U-904 2016-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204516-001 8658663 2029-04-06 U-904 Drug substance, Drug product 2014-03-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204516-001 7598271 2025-05-04 Drug substance 2013-07-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204516-001 8946251 2026-08-04 U-904 Drug substance, Drug product 2015-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204516-001 9393237 2026-08-04 U-904 2016-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204516-001 8658663 2029-04-06 U-904 Drug substance, Drug product 2014-03-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204516-001 7598271 2025-05-04 Drug substance 2013-07-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204516-001 8946251 2026-08-04 U-904 Drug substance, Drug product 2015-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204516-001 9393237 2026-08-04 U-904 2016-08-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204516-001 8658663 2029-04-06 U-904 Drug substance, Drug product 2014-03-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204516-001 7598271 2025-05-04 Drug substance 2013-07-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204516-001 8946251 2026-08-04 U-904 Drug substance, Drug product 2015-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204516-001 9393237 2026-08-04 U-904 2016-08-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204516-001 8658663 2029-04-06 U-904 Drug substance, Drug product 2014-03-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204516-001 7598271 2025-05-04 Drug substance 2013-07-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204516-001 8946251 2026-08-04 U-904 Drug substance, Drug product 2015-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204516-001 9393237 2026-08-04 U-904 2016-08-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204516-001 8658663 2029-04-06 U-904 Drug substance, Drug product 2014-03-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204516-001 7598271 2025-05-04 Drug substance 2013-07-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204516-001 8946251 2026-08-04 U-904 Drug substance, Drug product 2015-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204516-001 9393237 2026-08-04 U-904 2016-08-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204516-001 8658663 2029-04-06 U-904 Drug substance, Drug product 2014-03-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204516-001 7598271 2025-05-04 Drug substance 2013-07-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204516-001 8946251 2026-08-04 U-904 Drug substance, Drug product 2015-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204516-001 9393237 2026-08-04 U-904 2016-08-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204516-001 8658663 2029-04-06 U-904 Drug substance, Drug product 2014-03-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204516-001 7598271 2025-05-04 Drug substance 2013-07-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204516-001 8946251 2026-08-04 U-904 Drug substance, Drug product 2015-02-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204516-001 9393237 2026-08-04 U-904 2016-08-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204516-001 8658663 2029-04-06 U-904 Drug substance, Drug product 2014-03-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204516-001 7598271 2025-05-04 Drug substance 2013-07-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204516-001 8946251 2026-08-04 U-904 Drug substance, Drug product 2015-02-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204516-001 9393237 2026-08-04 U-904 2016-08-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204516-001 8658663 2029-04-06 U-904 Drug substance, Drug product 2014-03-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204516-001 7598271 2025-05-04 Drug substance 2013-07-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204516-001 8946251 2026-08-04 U-904 Drug substance, Drug product 2015-02-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204516-001 9393237 2026-08-04 U-904 2016-08-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204516-001 8658663 2029-04-06 U-904 Drug substance, Drug product 2014-03-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204516-001 7598271 2025-05-04 Drug substance 2013-07-11 79d66fd596c7…
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54766-907-53 54766090753 30 CAPSULE in 1 BLISTER PACK (54766-907-53) 30 capsule 2017-05-23 0000-00-00 No No Current