PAROXETINE

Product NDC: 71610-992
11-digit product format: 716100992
Labeler code: 71610
Product ID: 71610-992_4d3b40a4-5332-7664-e063-6394a90aed00
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: paroxetine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA075356
Marketing category: ANDA
Marketing start: 2003-07-30
Substance: PAROXETINE HYDROCHLORIDE ANHYDROUS
Active strength: 40 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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	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 · 164 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
2026-02-19 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…`
2024-10-29 15:01 UTC	2024-10	A075356-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2003-07-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075356-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2003-07-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075356-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2003-07-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075356-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2003-07-30	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-10-29 15:01 UTC	2024-10	A075356-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075356-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075356-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075356-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: PAROXETINE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PAROXETINE HYDROCHLORIDE ANHYDROUS	40 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
4d3b4536-7900-223c-e063-6294a90a3d60	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
71610-992-30	PAROXETINE	30 in 1 BOTTLE	TABLET, FILM COATED	30	1
71610-992-45	PAROXETINE	45 in 1 BOTTLE	TABLET, FILM COATED	45	1
71610-992-53	PAROXETINE	60 in 1 BOTTLE	TABLET, FILM COATED	60	1
71610-992-60	PAROXETINE	90 in 1 BOTTLE	TABLET, FILM COATED	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-992-30	EA - Each	71610-992	5a24e64f-4e19-4bc1-8294-a7ac2557e471	1	2026-04-20
71610-992-45	EA - Each	71610-992	0fe3a389-fddf-4ea9-967f-f3856b038b29	1	2026-04-20
71610-992-53	EA - Each	71610-992	b6a2eb77-a001-4e6c-8e13-69b150b29a39	1	2026-04-20
71610-992-60	EA - Each	71610-992	eb2c16ba-ff76-4a41-bc65-a0a28215a44a	1	2026-04-20

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 ndc (product): 71610-992
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
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
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	4d3b4536-7900-223c-e063-6294a90a3d60	1
1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD	4d3b4536-7900-223c-e063-6294a90a3d60	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71610-992-30	71610099230	30 TABLET, FILM COATED in 1 BOTTLE (71610-992-30)	2026-03-17	No	No	Current
71610-992-45	71610099245	45 TABLET, FILM COATED in 1 BOTTLE (71610-992-45)	2026-03-17	No	No	Current
71610-992-53	71610099253	60 TABLET, FILM COATED in 1 BOTTLE (71610-992-53)	2026-03-17	No	No	Current
71610-992-60	71610099260	90 TABLET, FILM COATED in 1 BOTTLE (71610-992-60)	2026-03-17	No	No	Current