Paroxetine

Product NDC: 59746-457
11-digit product format: 597460457
Labeler code: 59746
Product ID: 59746-457_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: 10 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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	59746-457		D	Discontinued by firm	2026-08-03
excluded package	package	59746-457	59746-457-01	D	Discontinued by firm	2026-08-03
excluded package	package	59746-457	59746-457-10	D	Discontinued by firm	2026-08-03
excluded package	package	59746-457	59746-457-30	D	Discontinued by firm	2026-08-03
excluded package	package	59746-457	59746-457-90	D	Discontinued by firm	2026-08-03

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 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	59746-457-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59746-457-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59746-457-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59746-457-30	`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	59746-457-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59746-457-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59746-457-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59746-457-30	`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	59746-457-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59746-457-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59746-457-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59746-457-30	`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	59746-457-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59746-457-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59746-457-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59746-457-30	`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	59746-457-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59746-457-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59746-457-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59746-457-30	`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	59746-457-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59746-457-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59746-457-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59746-457-30	`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	59746-457-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59746-457-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59746-457-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59746-457-30	`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	59746-457-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59746-457-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59746-457-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59746-457-30	`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	59746-457-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59746-457-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59746-457-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59746-457-30	`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	59746-457-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59746-457-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59746-457-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59746-457-30	`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	59746-457-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59746-457-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59746-457-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59746-457-30	`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	59746-457-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59746-457-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59746-457-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59746-457-30	`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	Approval date
A205528-001	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2015-11-27
A205528-002	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2015-11-27
A205528-003	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2015-11-27
A205528-004	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2015-11-27

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205528-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2015-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205528-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2015-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205528-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2015-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205528-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2015-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205528-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2015-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205528-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2015-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205528-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2015-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205528-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2015-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205528-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2015-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205528-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2015-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205528-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2015-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205528-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2015-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205528-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2015-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205528-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2015-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205528-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2015-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205528-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2015-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205528-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2015-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205528-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2015-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205528-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2015-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205528-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2015-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205528-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2015-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205528-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2015-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205528-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2015-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205528-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2015-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205528-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2015-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205528-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2015-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205528-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2015-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205528-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2015-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205528-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2015-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205528-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2015-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205528-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2015-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205528-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2015-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205528-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2015-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205528-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2015-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205528-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2015-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205528-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2015-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205528-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2015-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205528-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2015-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205528-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2015-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205528-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2015-11-27	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A205528-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205528-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205528-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205528-004	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A205528-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205528-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205528-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205528-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205528-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205528-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205528-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205528-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205528-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205528-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205528-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205528-004	AB	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59746-457-10	EA - Each	59746-457	0d57a86d-110f-4551-ac0b-57c9659912f2	1	2017-04-05
59746-457-30	EA - Each	59746-457	ddee82dd-3b3b-4f62-a210-b92068493dbd	1	2017-04-05
59746-457-90	EA - Each	59746-457	b1d5a46f-8143-4e17-ad9a-e3338f1a75ae	1	2017-04-05

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X2ELS050D8	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	110429-35-1	PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRESCRIBING INFORMATION PAROXETINE tablets, USP Rx Only	Jubilant Cadista Pharmaceuticals Inc. \| Jubilant Generics Limited \| Jubilant Generics Limited, Roorkee	2018-01-11	HUMAN PRESCRIPTION DRUG LABEL	7