Paroxetine

Product NDC: 68071-4315
11-digit product format: 680714315
Labeler code: 68071
Product ID: 68071-4315_66d52ffb-7473-6de9-e053-2a91aa0a909b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: paroxetine hydrochloride hemihydrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68071-4315		D	Discontinued by firm	2026-08-07
excluded package	package	68071-4315	68071-4315-6	D	Discontinued by firm	2026-08-07
excluded package	package	68071-4315	68071-4315-9	D	Discontinued by firm	2026-08-07

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 · 36 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	68071-4315-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-4315-9	`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	68071-4315-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-4315-9	`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	68071-4315-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-4315-9	`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	68071-4315-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-4315-9	`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	68071-4315-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-4315-9	`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	68071-4315-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-4315-9	`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	68071-4315-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-4315-9	`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	68071-4315-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-4315-9	`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	68071-4315-6	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-4315-9	`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	68071-4315-6	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-4315-9	`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	68071-4315-6	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-4315-9	`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	68071-4315-6	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-4315-9	`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…`

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	NuCare Pharmaceuticals,Inc.	2018-03-07	HUMAN PRESCRIPTION DRUG LABEL	1

Paroxetine

NDC auxiliary status#

Observed NDC auxiliary status history#

Orange Book products#

Observed Orange Book product history#

Observed Orange Book normalized TE history#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#