Home NDC 0574-0279 Paroxetine
Product NDC 0574-0279
11-digit product format 005740279
Labeler code 0574
Product ID 0574-0279_2da9c1a5-7b6c-4990-b6a5-1b06e1dd85cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name paroxetine
Dosage form CAPSULE
Route ORAL
Labeler Padagis US LLC
Application NDA204516
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2017-10-03
Substance PAROXETINE MESYLATE
Active strength 7.5 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
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-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…
Additional Listing Data#
Finished product Yes
Brand name base Paroxetine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PAROXETINE MESYLATE 7.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination M711N184JE Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1430122 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0574-0279-30 Paroxetine 30 in 1 BOTTLE CAPSULE 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0574-0279 PAROXETINE CAPSULE [PADAGIS US LLC] 5 Current NDC, Legacy NDC, 1 package rows 20230922_1383d713-79b9-45bd-bd06-65707f28bc99.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0574-0279-30 00574027930 30 CAPSULE in 1 BOTTLE (0574-0279-30) 30 capsule 2017-10-03 0000-00-00 No No Current