PAROXETINE

Product NDC: 60505-0084
11-digit product format: 605050084
Labeler code: 60505
Product ID: 60505-0084_9cde2ef4-fd50-ed21-0628-cb6cd8a6153f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: paroxetine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA075356
Marketing category: ANDA
Marketing start: 2003-09-08
Substance: PAROXETINE HYDROCHLORIDE ANHYDROUS
Active strength: 30 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 package	package	60505-0084	60505-0084-5	D	Discontinued by firm		2026-08-17
excluded package	package	60505-0084	60505-0084-9	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, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	60505-0084-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	60505-0084-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	60505-0084-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	60505-0084-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	60505-0084-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	60505-0084-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	60505-0084-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	60505-0084-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	60505-0084-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	60505-0084-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	60505-0084-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	60505-0084-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	60505-0084-9	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	60505-0084-5	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	60505-0084-9	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	60505-0084-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	60505-0084-9	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	60505-0084-5	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	60505-0084-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	60505-0084-9	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	60505-0084-5	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	60505-0084-9	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	60505-0084-5	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	60505-0084-9	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

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	Approval date
A075356-001	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2003-07-30
A075356-002	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2003-07-30
A075356-003	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2003-07-30
A075356-004	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2003-07-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A075356-001	AB
A075356-002	AB
A075356-003	AB
A075356-004	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 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075356-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2003-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075356-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2003-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075356-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2003-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075356-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2003-07-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075356-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2003-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075356-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2003-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075356-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2003-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075356-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2003-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075356-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2003-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075356-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2003-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075356-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2003-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075356-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2003-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075356-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2003-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075356-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2003-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075356-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2003-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075356-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2003-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075356-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2003-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075356-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2003-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075356-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2003-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075356-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2003-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075356-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2003-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075356-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2003-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075356-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2003-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075356-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2003-07-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075356-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2003-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075356-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2003-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075356-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2003-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075356-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2003-07-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075356-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2003-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075356-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2003-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075356-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2003-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075356-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2003-07-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075356-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2003-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075356-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2003-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075356-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2003-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075356-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2003-07-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075356-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2003-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075356-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2003-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075356-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2003-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075356-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2003-07-30	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A075356-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075356-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075356-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075356-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075356-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075356-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075356-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075356-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075356-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075356-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075356-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075356-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075356-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075356-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075356-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075356-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075356-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075356-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075356-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075356-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075356-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075356-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075356-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075356-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075356-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075356-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075356-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075356-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075356-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075356-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075356-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075356-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075356-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075356-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075356-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075356-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075356-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075356-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075356-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075356-004	AB	1	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: PAROXETINE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PAROXETINE HYDROCHLORIDE ANHYDROUS	30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3I3T11UD2S	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1738483	Internal RxNorm lookup
1738495	Internal RxNorm lookup
1738503	Internal RxNorm lookup
1738511	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
08320ea3-8f93-6f04-5d1c-f69af3eb5a81	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2ace441e-5ed1-9a56-64e5-302d887093bd	Product name	7	20250107
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60505-0084-1	PAROXETINE	30 in 1 BOTTLE	TABLET, FILM COATED	30	25
60505-0084-2	PAROXETINE	100 in 1 BOTTLE	TABLET, FILM COATED	100	25
60505-0084-4	PAROXETINE	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	25
60505-0084-5	PAROXETINE	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	25
60505-0084-5	PAROXETINE	10 in 1 CARTON	TABLET, FILM COATED	10	25
60505-0084-9	PAROXETINE	90 in 1 BOTTLE	TABLET, FILM COATED	90	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-0084-1	EA - Each	60505-0084	59db11de-be77-4ee6-824c-bee7a731908d	1	2012-07-24
60505-0084-2	EA - Each	60505-0084	fa059b40-4016-416f-ae3f-8c908078b666	1	2012-07-24
60505-0084-4	EA - Each	60505-0084	e797d8aa-cb58-446d-a66a-41073b54f061	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PAROXETINE HYDROCHLORIDE ANHYDROUS	ACTIVE INGREDIENT	3I3T11UD2S	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.]	11
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.]	11
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.]	11
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.]	11
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.]	11
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.]	11
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.]	11
PAROXETINE HYDROCHLORIDE ANHYDROUS	ACTIVE INGREDIENT	3I3T11UD2S	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
PAROXETINE HYDROCHLORIDE ANHYDROUS	ACTIVE INGREDIENT	3I3T11UD2S	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	4
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	4
PAROXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	3I3T11UD2S	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
PAROXETINE HYDROCHLORIDE ANHYDROUS	ACTIVE INGREDIENT	3I3T11UD2S	PAROXETINE TABLET, FILM COATED [DIRECTRX]	1
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE TABLET, FILM COATED [DIRECTRX]	1
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PAROXETINE TABLET, FILM COATED [DIRECTRX]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	PAROXETINE TABLET, FILM COATED [DIRECTRX]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE TABLET, FILM COATED [DIRECTRX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE TABLET, FILM COATED [DIRECTRX]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PAROXETINE TABLET, FILM COATED [DIRECTRX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PAROXETINE TABLET, FILM COATED [DIRECTRX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE TABLET, FILM COATED [DIRECTRX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-0084	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.]	24	Current NDC, Legacy NDC, 6 package rows	20250411_08320ea3-8f93-6f04-5d1c-f69af3eb5a81.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PAROXETINE	PAROXETINE HYDROCHLORIDE	REMEDYREPACK INC.	8e176ff2-ed3a-4909-94e1-6b9a3581a621	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075356 application number: ANDA075356
PAROXETINE	PAROXETINE HYDROCHLORIDE	REMEDYREPACK INC.	beb87e2e-0a8f-43b6-b148-57f0b7191548	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075356 application number: ANDA075356
PAROXETINE	PAROXETINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	e63fe922-b35a-406c-8737-f3f5e6d5a30d	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075356 application number: ANDA075356
PAROXETINE	PAROXETINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4d3b4536-7900-223c-e063-6294a90a3d60	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075356 application number: ANDA075356
PAROXETINE	PAROXETINE HYDROCHLORIDE	REMEDYREPACK INC.	98d4f767-06e3-4d9b-b1ad-4b31f7e36130	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075356 application number: ANDA075356
PAROXETINE	PAROXETINE HYDROCHLORIDE	Cardinal Health 107, LLC	333dfd07-61f0-4b86-b4b5-b04adf64e49f	2025-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075356 application number: ANDA075356
PAROXETINE	PAROXETINE HYDROCHLORIDE	Major Pharmaceuticals	84b1b1f0-d375-4fda-99af-9487f8ef50c7	2025-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075356 application number: ANDA075356
PAROXETINE	PAROXETINE HYDROCHLORIDE	Apotex Corp.	08320ea3-8f93-6f04-5d1c-f69af3eb5a81	2025-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075356 application number: ANDA075356 ndc (product): 60505-0084
PAROXETINE	PAROXETINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	1801246b-02c3-430f-932a-b18cb0d13d1d	2018-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075356 application number: ANDA075356
PAROXETINE	PAROXETINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	a7128be7-7023-40c4-aa64-29d52145ae31	2018-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075356 application number: ANDA075356

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3I3T11UD2S	PAROXETINE HYDROCHLORIDE ANHYDROUS	78246-49-8	PAROXETINE HYDROCHLORIDE ANHYDROUS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	08320ea3-8f93-6f04-5d1c-f69af3eb5a81	25
1738495	PARoxetine HCl 20 MG Oral Tablet	PSN	08320ea3-8f93-6f04-5d1c-f69af3eb5a81	25
1738503	PARoxetine HCl 30 MG Oral Tablet	PSN	08320ea3-8f93-6f04-5d1c-f69af3eb5a81	25
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	08320ea3-8f93-6f04-5d1c-f69af3eb5a81	25
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	08320ea3-8f93-6f04-5d1c-f69af3eb5a81	25
1738495	paroxetine hydrochloride 20 MG Oral Tablet	SCD	08320ea3-8f93-6f04-5d1c-f69af3eb5a81	25
1738503	paroxetine hydrochloride 30 MG Oral Tablet	SCD	08320ea3-8f93-6f04-5d1c-f69af3eb5a81	25
1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD	08320ea3-8f93-6f04-5d1c-f69af3eb5a81	25
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	84b1b1f0-d375-4fda-99af-9487f8ef50c7	19
1738495	PARoxetine HCl 20 MG Oral Tablet	PSN	84b1b1f0-d375-4fda-99af-9487f8ef50c7	19
1738503	PARoxetine HCl 30 MG Oral Tablet	PSN	84b1b1f0-d375-4fda-99af-9487f8ef50c7	19
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	84b1b1f0-d375-4fda-99af-9487f8ef50c7	19
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	84b1b1f0-d375-4fda-99af-9487f8ef50c7	19
1738495	paroxetine hydrochloride 20 MG Oral Tablet	SCD	84b1b1f0-d375-4fda-99af-9487f8ef50c7	19
1738503	paroxetine hydrochloride 30 MG Oral Tablet	SCD	84b1b1f0-d375-4fda-99af-9487f8ef50c7	19
1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD	84b1b1f0-d375-4fda-99af-9487f8ef50c7	19
1738503	PARoxetine HCl 30 MG Oral Tablet	PSN	8e176ff2-ed3a-4909-94e1-6b9a3581a621	18
1738503	paroxetine hydrochloride 30 MG Oral Tablet	SCD	8e176ff2-ed3a-4909-94e1-6b9a3581a621	18
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	e63fe922-b35a-406c-8737-f3f5e6d5a30d	17
1738495	PARoxetine HCl 20 MG Oral Tablet	PSN	e63fe922-b35a-406c-8737-f3f5e6d5a30d	17
1738503	PARoxetine HCl 30 MG Oral Tablet	PSN	e63fe922-b35a-406c-8737-f3f5e6d5a30d	17
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	e63fe922-b35a-406c-8737-f3f5e6d5a30d	17
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	e63fe922-b35a-406c-8737-f3f5e6d5a30d	17
1738495	paroxetine hydrochloride 20 MG Oral Tablet	SCD	e63fe922-b35a-406c-8737-f3f5e6d5a30d	17
1738503	paroxetine hydrochloride 30 MG Oral Tablet	SCD	e63fe922-b35a-406c-8737-f3f5e6d5a30d	17
1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD	e63fe922-b35a-406c-8737-f3f5e6d5a30d	17
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	a93796a3-56fc-4af6-99ba-f76707c32e5d	5
1738495	PARoxetine HCl 20 MG Oral Tablet	PSN	a93796a3-56fc-4af6-99ba-f76707c32e5d	5
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	a93796a3-56fc-4af6-99ba-f76707c32e5d	5
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	a93796a3-56fc-4af6-99ba-f76707c32e5d	5
1738495	paroxetine hydrochloride 20 MG Oral Tablet	SCD	a93796a3-56fc-4af6-99ba-f76707c32e5d	5
1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD	a93796a3-56fc-4af6-99ba-f76707c32e5d	5
1738503	PARoxetine HCl 30 MG Oral Tablet	PSN	79b0eb99-95f8-4db4-ba30-503f32538ab8	3
1738503	paroxetine hydrochloride 30 MG Oral Tablet	SCD	79b0eb99-95f8-4db4-ba30-503f32538ab8	3
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	c9b57101-2455-463d-b8d7-b2316cecd67a	1
1738495	PARoxetine HCl 20 MG Oral Tablet	PSN	c9b57101-2455-463d-b8d7-b2316cecd67a	1
1738503	PARoxetine HCl 30 MG Oral Tablet	PSN	c9b57101-2455-463d-b8d7-b2316cecd67a	1
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	c9b57101-2455-463d-b8d7-b2316cecd67a	1
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	c9b57101-2455-463d-b8d7-b2316cecd67a	1
1738495	paroxetine hydrochloride 20 MG Oral Tablet	SCD	c9b57101-2455-463d-b8d7-b2316cecd67a	1
1738503	paroxetine hydrochloride 30 MG Oral Tablet	SCD	c9b57101-2455-463d-b8d7-b2316cecd67a	1
1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD	c9b57101-2455-463d-b8d7-b2316cecd67a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-0084-1	60505008401	30 TABLET, FILM COATED in 1 BOTTLE (60505-0084-1)		2003-09-08	0000-00-00	No	No	Current
60505-0084-2	60505008402	100 TABLET, FILM COATED in 1 BOTTLE (60505-0084-2)		2003-09-08	0000-00-00	No	No	Current
60505-0084-4	60505008404	1000 TABLET, FILM COATED in 1 BOTTLE (60505-0084-4)		2003-09-08	0000-00-00	No	No	Current
60505-0084-5	60505008405	10 BLISTER PACK in 1 CARTON (60505-0084-5) > 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2003-09-08	0000-00-00	No	No	Current
60505-0084-9	60505008409	90 TABLET, FILM COATED in 1 BOTTLE (60505-0084-9)		2003-09-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PAROXETINE	REMEDYREPACK INC.	2026-07-06	HUMAN PRESCRIPTION DRUG LABEL	19
PAROXETINE	Golden State Medical Supply, Inc.	2026-05-27	HUMAN PRESCRIPTION DRUG LABEL	17
PAROXETINE	Major Pharmaceuticals	2025-08-07	HUMAN PRESCRIPTION DRUG LABEL	19
PAROXETINE	Apotex Corp. \| Apotex Inc.	2025-07-24	HUMAN PRESCRIPTION DRUG LABEL	25
PAROXETINE	DirectRX	2019-04-19	HUMAN PRESCRIPTION DRUG LABEL	3
PAROXETINE TABLETS 10 mg, 20 mg, 30 mg and 40 mg	Physicians Total Care, Inc.	2012-09-10	HUMAN PRESCRIPTION DRUG LABEL	5
PAROXETINE TABLETS USP 10 mg, 20 mg, 30 mg and 40 mg	State of Florida DOH Central Pharmacy	2010-05-29	HUMAN PRESCRIPTION DRUG LABEL	1