PAROXETINE HYDROCHLORIDE

Product NDC: 60505-3674
11-digit product format: 605053674
Labeler code: 60505
Product ID: 60505-3674_97c5413a-415b-55a7-245b-33a8c519ee5d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: paroxetine hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Apotex Corp
Application: NDA020936
Marketing category: NDA
Marketing start: 2010-09-13
Marketing end: 2023-01-31
Substance: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength: 25 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	60505-3674		D	Discontinued by firm		2026-08-17
excluded package	package	60505-3674	60505-3674-3	D	Discontinued by firm		2026-08-17

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	60505-3674-3	`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	60505-3674-3	`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	60505-3674-3	`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	60505-3674-3	`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	60505-3674-3	`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	60505-3674-3	`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	60505-3674-3	`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	60505-3674-3	`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	60505-3674-3	`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	60505-3674-3	`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	60505-3674-3	`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	60505-3674-3	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020936-001	PAXIL CR	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16
N020936-002	PAXIL CR	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16
N020936-003	PAXIL CR	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N020936-001	AB
N020936-002	AB
N020936-003	AB

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 4 · 126 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
2026-08-18 06:07:40	2026-07	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020936-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020936-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020936-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020936-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020936-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020936-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020936-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020936-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020936-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020936-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020936-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020936-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020936-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020936-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020936-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020936-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020936-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020936-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020936-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020936-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020936-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020936-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020936-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020936-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020936-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020936-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020936-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020936-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020936-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020936-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020936-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020936-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020936-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020936-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020936-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020936-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020936-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020936-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020936-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020936-001	AB	1	`1e350fbaab3a…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2ace441e-5ed1-9a56-64e5-302d887093bd	Product name	7	20250107
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
ba9fc237-0e76-4ac8-d3c5-cdb4df9e9f7f	Product name	4	20220524
200c61bf-0879-1df7-72b7-b72a8497b114	Product name	3	20171006
b430fc19-562d-420b-53a2-64d42b938631	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60505-3674-3	2020-08-25	C162847	48780-1	ab0e2407-31cc-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use Paroxetine HCL CR safely and effectively. See full prescribing information for Paroxetine HCL CR . PAROXETINE HCL CR (paroxetine) extended-release tablets, for oral use Initial U.S. Approval: 1992
60505-3674-3	2020-07-22	C162847	48780-1	ab0e2407-31cc-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use Paroxetine HCL CR safely and effectively. See full prescribing information for Paroxetine HCL CR . PAROXETINE HCL CR (paroxetine) extended-release tablets, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60505-3674-3	PAROXETINE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-3674-3	EA - Each	60505-3674	737882dc-b082-488a-be1d-1866bdf6ca91	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PAROXETINE HYDROCHLORIDE HEMIHYDRATE	ACTIVE INGREDIENT	X2ELS050D8	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]	8
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]	8
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]	8
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]	8
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]	8
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]	8
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]	8
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]	8
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-3674	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]	17	Legacy NDC, 1 package rows	20240504_087ff0d3-1761-47ea-a8c1-7c4cb679af97.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PAXIL CR	PAROXETINE HYDROCHLORIDE	Apotex Corp	483bd97f-c4d0-4e23-aaa8-6334f4471e0c	2025-09-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020936 application number: NDA020936
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	Apotex Corp	087ff0d3-1761-47ea-a8c1-7c4cb679af97	2025-09-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020936 application number: NDA020936 ndc (product): 60505-3674

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1738803	PARoxetine HCl 12.5 MG 24HR Extended Release Oral Tablet	PSN	087ff0d3-1761-47ea-a8c1-7c4cb679af97	18
1738805	PARoxetine HCl 25 MG 24HR Extended Release Oral Tablet	PSN	087ff0d3-1761-47ea-a8c1-7c4cb679af97	18
1738807	PARoxetine HCl 37.5 MG 24HR Extended Release Oral Tablet	PSN	087ff0d3-1761-47ea-a8c1-7c4cb679af97	18
1738803	24 HR paroxetine hydrochloride 12.5 MG Extended Release Oral Tablet	SCD	087ff0d3-1761-47ea-a8c1-7c4cb679af97	18
1738805	24 HR paroxetine hydrochloride 25 MG Extended Release Oral Tablet	SCD	087ff0d3-1761-47ea-a8c1-7c4cb679af97	18
1738807	24 HR paroxetine hydrochloride 37.5 MG Extended Release Oral Tablet	SCD	087ff0d3-1761-47ea-a8c1-7c4cb679af97	18
1738803	paroxetine hydrochloride 12.5 MG 24 HR Extended Release Oral Tablet	SY	087ff0d3-1761-47ea-a8c1-7c4cb679af97	18
1738805	paroxetine hydrochloride 25 MG 24 HR Extended Release Oral Tablet	SY	087ff0d3-1761-47ea-a8c1-7c4cb679af97	18
1738807	paroxetine hydrochloride 37.5 MG 24 HR Extended Release Oral Tablet	SY	087ff0d3-1761-47ea-a8c1-7c4cb679af97	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-3674-3	60505367403	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-3674-3)	2010-09-13	2023-01-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PAROXETINE HYDROCHLORIDE	Apotex Corp \| Apotex Inc.	2025-09-22	HUMAN PRESCRIPTION DRUG LABEL	18
PAROXETINE HYDROCHLORIDE	REMEDYREPACK INC.	2019-12-17	HUMAN PRESCRIPTION DRUG LABEL	3