Home NDC 54766-202 PEXEVA
Product NDC 54766-202
11-digit product format 547660202
Labeler code 54766
Product ID 54766-202_e30fbd74-babc-9f31-e053-2995a90a73d4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name paroxetine mesylate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sebela Pharmaceuticals Inc.
Application NDA021299
Marketing category NDA
Marketing start 2017-06-02
Marketing end 0000-00-00
Substance PAROXETINE MESYLATE
Active strength 20 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
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 54766-202-01 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 54766-202-01 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 54766-202-01 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 54766-202-01 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 54766-202-01 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 54766-202-01 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 54766-202-01 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 54766-202-01 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 54766-202-01 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 54766-202-01 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 54766-202-01 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 54766-202-01 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021299-001 PEXEVA PAROXETINE MESYLATE EQ 10MG BASE TABLET / ORAL RLD 2003-07-03 N021299-002 PEXEVA PAROXETINE MESYLATE EQ 20MG BASE TABLET / ORAL RLD 2003-07-03 N021299-003 PEXEVA PAROXETINE MESYLATE EQ 30MG BASE TABLET / ORAL RLD 2003-07-03 N021299-004 PEXEVA PAROXETINE MESYLATE EQ 40MG BASE TABLET / ORAL RLD 2003-07-03
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 5 · 164 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 N021299-001 PEXEVA EQ 10MG BASE TABLET / ORAL RLD 2003-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021299-002 PEXEVA EQ 20MG BASE TABLET / ORAL RLD 2003-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021299-003 PEXEVA EQ 30MG BASE TABLET / ORAL RLD 2003-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021299-004 PEXEVA EQ 40MG BASE TABLET / ORAL RLD 2003-07-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021299-001 PEXEVA EQ 10MG BASE TABLET / ORAL RLD 2003-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021299-002 PEXEVA EQ 20MG BASE TABLET / ORAL RLD 2003-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021299-003 PEXEVA EQ 30MG BASE TABLET / ORAL RLD 2003-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021299-004 PEXEVA EQ 40MG BASE TABLET / ORAL RLD 2003-07-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021299-001 PEXEVA EQ 10MG BASE TABLET / ORAL RLD 2003-07-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021299-002 PEXEVA EQ 20MG BASE TABLET / ORAL RLD 2003-07-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021299-003 PEXEVA EQ 30MG BASE TABLET / ORAL RLD 2003-07-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021299-004 PEXEVA EQ 40MG BASE TABLET / ORAL RLD 2003-07-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021299-001 PEXEVA EQ 10MG BASE TABLET / ORAL RLD 2003-07-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021299-002 PEXEVA EQ 20MG BASE TABLET / ORAL RLD 2003-07-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021299-003 PEXEVA EQ 30MG BASE TABLET / ORAL RLD 2003-07-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021299-004 PEXEVA EQ 40MG BASE TABLET / ORAL RLD 2003-07-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021299-001 PEXEVA EQ 10MG BASE TABLET / ORAL RLD 2003-07-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021299-002 PEXEVA EQ 20MG BASE TABLET / ORAL RLD 2003-07-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021299-003 PEXEVA EQ 30MG BASE TABLET / ORAL RLD 2003-07-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021299-004 PEXEVA EQ 40MG BASE TABLET / ORAL RLD 2003-07-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021299-001 PEXEVA EQ 10MG BASE TABLET / ORAL RLD 2003-07-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021299-002 PEXEVA EQ 20MG BASE TABLET / ORAL RLD 2003-07-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021299-003 PEXEVA EQ 30MG BASE TABLET / ORAL RLD 2003-07-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021299-004 PEXEVA EQ 40MG BASE TABLET / ORAL RLD 2003-07-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021299-001 PEXEVA EQ 10MG BASE TABLET / ORAL RLD 2003-07-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021299-002 PEXEVA EQ 20MG BASE TABLET / ORAL RLD 2003-07-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021299-003 PEXEVA EQ 30MG BASE TABLET / ORAL RLD 2003-07-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021299-004 PEXEVA EQ 40MG BASE TABLET / ORAL RLD 2003-07-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021299-001 PEXEVA EQ 10MG BASE TABLET / ORAL RLD 2003-07-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021299-002 PEXEVA EQ 20MG BASE TABLET / ORAL RLD 2003-07-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021299-003 PEXEVA EQ 30MG BASE TABLET / ORAL RLD 2003-07-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021299-004 PEXEVA EQ 40MG BASE TABLET / ORAL RLD 2003-07-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021299-001 PEXEVA EQ 10MG BASE TABLET / ORAL RLD 2003-07-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021299-002 PEXEVA EQ 20MG BASE TABLET / ORAL RLD 2003-07-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021299-003 PEXEVA EQ 30MG BASE TABLET / ORAL RLD 2003-07-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021299-004 PEXEVA EQ 40MG BASE TABLET / ORAL RLD 2003-07-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021299-001 PEXEVA EQ 10MG BASE TABLET / ORAL RLD 2003-07-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021299-002 PEXEVA EQ 20MG BASE TABLET / ORAL RLD 2003-07-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021299-003 PEXEVA EQ 30MG BASE TABLET / ORAL RLD 2003-07-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021299-004 PEXEVA EQ 40MG BASE TABLET / ORAL RLD 2003-07-03 d06236e962d9…
Observed Orange Book patent history# Patent history page 1 of 4 · 156 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021299-001 7598271 2025-05-04 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021299-002 7598271 2025-05-04 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021299-003 7598271 2025-05-04 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021299-004 7598271 2025-05-04 Drug substance 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021299-001 7598271 2025-05-04 Drug substance 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021299-002 7598271 2025-05-04 Drug substance 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021299-003 7598271 2025-05-04 Drug substance 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021299-004 7598271 2025-05-04 Drug substance 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021299-001 7598271 2025-05-04 Drug substance fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021299-002 7598271 2025-05-04 Drug substance fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021299-003 7598271 2025-05-04 Drug substance fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021299-004 7598271 2025-05-04 Drug substance fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021299-001 7598271 2025-05-04 Drug substance b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021299-002 7598271 2025-05-04 Drug substance b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021299-003 7598271 2025-05-04 Drug substance b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021299-004 7598271 2025-05-04 Drug substance b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021299-001 7598271 2025-05-04 Drug substance 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021299-002 7598271 2025-05-04 Drug substance 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021299-003 7598271 2025-05-04 Drug substance 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021299-004 7598271 2025-05-04 Drug substance 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021299-001 7598271 2025-05-04 Drug substance 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021299-002 7598271 2025-05-04 Drug substance 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021299-003 7598271 2025-05-04 Drug substance 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021299-004 7598271 2025-05-04 Drug substance 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021299-001 7598271 2025-05-04 Drug substance 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021299-002 7598271 2025-05-04 Drug substance 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021299-003 7598271 2025-05-04 Drug substance 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021299-004 7598271 2025-05-04 Drug substance 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021299-001 7598271 2025-05-04 Drug substance d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021299-002 7598271 2025-05-04 Drug substance d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021299-003 7598271 2025-05-04 Drug substance d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021299-004 7598271 2025-05-04 Drug substance d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021299-001 7598271 2025-05-04 Drug substance d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021299-002 7598271 2025-05-04 Drug substance d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021299-003 7598271 2025-05-04 Drug substance d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021299-004 7598271 2025-05-04 Drug substance d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021299-001 7598271 2025-05-04 Drug substance 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021299-002 7598271 2025-05-04 Drug substance 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021299-003 7598271 2025-05-04 Drug substance 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021299-004 7598271 2025-05-04 Drug substance 79d66fd596c7…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 54766-202-01 54766020201 30 TABLET, FILM COATED in 1 BOTTLE (54766-202-01) 2017-06-02 0000-00-00 No No Current