Paroxetine

Product NDC
59746-458
11-digit product format
597460458
Labeler code
59746
Product ID
59746-458_304e02c2-48d3-4f9e-a7de-8d9be564580b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride hemihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Jubilant Cadista Pharmaceuticals Inc.
Application
ANDA205528
Marketing category
ANDA
Marketing start
2015-11-20
Marketing end
0000-00-00
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
20 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59746-458DDiscontinued by firm2026-08-03
excluded packagepackage59746-45859746-458-01DDiscontinued by firm2026-08-03
excluded packagepackage59746-45859746-458-10DDiscontinued by firm2026-08-03
excluded packagepackage59746-45859746-458-30DDiscontinued by firm2026-08-03
excluded packagepackage59746-45859746-458-90DDiscontinued by firm2026-08-03

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 · 60 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59746-458-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59746-458-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59746-458-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59746-458-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59746-458-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59746-458-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59746-458-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59746-458-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59746-458-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59746-458-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59746-458-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59746-458-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59746-458-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59746-458-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59746-458-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59746-458-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59746-458-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59746-458-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59746-458-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59746-458-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59746-458-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59746-458-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59746-458-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59746-458-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59746-458-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59746-458-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59746-458-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59746-458-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59746-458-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59746-458-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59746-458-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59746-458-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59746-458-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59746-458-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59746-458-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59746-458-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59746-458-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59746-458-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59746-458-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59746-458-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59746-458-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59746-458-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59746-458-90367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59746-458-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59746-458-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59746-458-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59746-458-90557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59746-458-10557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205528-001PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2015-11-27
A205528-002PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2015-11-27
A205528-003PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2015-11-27
A205528-004PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2015-11-27

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A205528-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2015-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205528-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2015-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205528-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2015-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205528-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2015-11-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205528-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2015-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205528-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2015-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205528-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2015-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205528-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2015-11-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A205528-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2015-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205528-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2015-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205528-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2015-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205528-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2015-11-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205528-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2015-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205528-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2015-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205528-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2015-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205528-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2015-11-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205528-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2015-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205528-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2015-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205528-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2015-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205528-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2015-11-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205528-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2015-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205528-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2015-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205528-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2015-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205528-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2015-11-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205528-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2015-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205528-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2015-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205528-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2015-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205528-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2015-11-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205528-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2015-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205528-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2015-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205528-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2015-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205528-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2015-11-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205528-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2015-11-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205528-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2015-11-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205528-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2015-11-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205528-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2015-11-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205528-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2015-11-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A205528-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2015-11-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A205528-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2015-11-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A205528-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2015-11-27d06236e962d9…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A205528-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205528-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205528-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205528-004AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A205528-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A205528-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A205528-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A205528-004AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A205528-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A205528-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A205528-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A205528-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A205528-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A205528-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A205528-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A205528-004AB1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-458-10EA - Each59746-45865fccf31-182c-47d1-afa5-5d1f4bed0ff412017-04-05
59746-458-30EA - Each59746-458844271d4-899e-4f2e-9c9d-ccbfee184e2e12017-04-05
59746-458-90EA - Each59746-458da90f4cd-32de-4145-9488-0996fca4bd4c12017-04-05