PAROXETINE

Product NDC: 60505-0101
Requested package NDC: 60505-0101-5
11-digit product format: 605050101
Labeler code: 60505
Product ID: 60505-0101_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: 40 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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	60505-0101	60505-0101-5	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 6 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60505-0101	60505-0101-5	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60505-0101	60505-0101-5	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60505-0101	60505-0101-5	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60505-0101	60505-0101-5	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60505-0101	60505-0101-5	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60505-0101	60505-0101-5	D	Discontinued by firm	excluded / ndc_excluded.zip	`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	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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 (package): 60505-0101-5 ndc (product): 60505-0101 ndc11 (package): 60505010105
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

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	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 · 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
60505-0101-1	PAROXETINE	30 in 1 BOTTLE	TABLET, FILM COATED	30	25
60505-0101-2	PAROXETINE	100 in 1 BOTTLE	TABLET, FILM COATED	100	25
60505-0101-4	PAROXETINE	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	25
60505-0101-5	PAROXETINE	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	25
60505-0101-5	PAROXETINE	10 in 1 CARTON	TABLET, FILM COATED	10	25
60505-0101-7	PAROXETINE	7000 in 1 BOTTLE	TABLET, FILM COATED	7000	25
60505-0101-9	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
60505-0101-1	EA - Each	60505-0101	3ec0e11f-017e-46c6-8c69-84a9ec3bd5cb	1	2012-07-24
60505-0101-2	EA - Each	60505-0101	c38eb0bf-8267-4344-8a2b-f0ff30bca4a4	1	2012-07-24
60505-0101-4	EA - Each	60505-0101	6c87f629-4d54-4e36-b7e1-f24abc9fbfa2	1	2012-07-24
60505-0101-7	EA - Each	60505-0101	86d47f74-df25-4bf2-b64e-7573eaae4935	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 (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	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 (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	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 (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-0101	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.]	24	Current NDC, Legacy NDC, 7 package rows	20250411_08320ea3-8f93-6f04-5d1c-f69af3eb5a81.zip

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
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
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	beb87e2e-0a8f-43b6-b148-57f0b7191548	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
1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD	beb87e2e-0a8f-43b6-b148-57f0b7191548	17
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	d1909594-481b-456a-b302-a66ff42f8bd5	10
1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD	d1909594-481b-456a-b302-a66ff42f8bd5	10
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
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
1738495	PARoxetine HCl 20 MG Oral Tablet	PSN	857595e2-e58f-4537-a629-7cc85cdc9897	1
1738503	PARoxetine HCl 30 MG Oral Tablet	PSN	c9b57101-2455-463d-b8d7-b2316cecd67a	1
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	a7128be7-7023-40c4-aa64-29d52145ae31	1
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	c9b57101-2455-463d-b8d7-b2316cecd67a	1
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	857595e2-e58f-4537-a629-7cc85cdc9897	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
1738495	paroxetine hydrochloride 20 MG Oral Tablet	SCD	857595e2-e58f-4537-a629-7cc85cdc9897	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
1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD	a7128be7-7023-40c4-aa64-29d52145ae31	1
1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD	857595e2-e58f-4537-a629-7cc85cdc9897	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-0101-5	60505010105	10 BLISTER PACK in 1 CARTON (60505-0101-5) > 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2003-09-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PAROXETINE	REMEDYREPACK INC.	2026-07-02	HUMAN PRESCRIPTION DRUG LABEL	18
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 TABLETS, USP 10 mg, 20 mg, 30 mg and 40 mg Rx only	A-S Medication Solutions	2021-03-26	HUMAN PRESCRIPTION DRUG LABEL	10
PAROXETINE TABLETS, USP 10 mg, 20 mg, 30 mg and 40 mg Rx only	Aphena Pharma Solutions - Tennessee, LLC	2018-10-17	HUMAN PRESCRIPTION DRUG LABEL	1
PAROXETINE TABLETS, USP 10 mg, 20 mg, 30 mg and 40 mg Rx only	Blenheim Pharmacal, Inc.	2013-06-03	HUMAN PRESCRIPTION DRUG LABEL	1
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