Paroxetine Hydrochloride

Product NDC: 0378-2004
11-digit product format: 003782004
Labeler code: 0378
Product ID: 0378-2004_c0e82152-59ec-4ca4-8d1a-883ad52f98bb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: paroxetine hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA077873
Marketing category: ANDA
Marketing start: 2008-05-14
Marketing end: 2021-11-30
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	0378-2004		D	Discontinued by firm		2026-08-03
excluded package	package	0378-2004	0378-2004-93	D	Discontinued by firm		2026-08-03

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	0378-2004-93	`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	0378-2004-93	`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	0378-2004-93	`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	0378-2004-93	`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	0378-2004-93	`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	0378-2004-93	`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	0378-2004-93	`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	0378-2004-93	`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	0378-2004-93	`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	0378-2004-93	`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	0378-2004-93	`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	0378-2004-93	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077873-001	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2007-06-29
A077873-002	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2007-06-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A077873-001	AB
A077873-002	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 3 · 82 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	A077873-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077873-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077873-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077873-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077873-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077873-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077873-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077873-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077873-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077873-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077873-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077873-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077873-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077873-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077873-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077873-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077873-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077873-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077873-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077873-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077873-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077873-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077873-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077873-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077873-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077873-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077873-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077873-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077873-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077873-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077873-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077873-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077873-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077873-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077873-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077873-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077873-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077873-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077873-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077873-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2007-06-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A077873-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077873-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077873-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077873-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077873-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077873-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077873-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077873-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077873-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077873-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077873-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077873-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077873-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077873-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077873-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077873-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077873-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077873-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077873-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077873-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077873-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077873-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077873-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077873-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077873-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077873-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077873-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077873-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077873-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077873-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077873-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077873-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077873-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077873-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077873-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077873-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077873-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077873-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077873-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077873-002	AB	1	`782e0a99824c…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-2004-05	EA - Each	0378-2004	9cb25266-746c-4c3b-903c-204a346caeb3	1	2012-07-24
0378-2004-93	EA - Each	0378-2004	d8a37f7f-5f2a-46c5-85c8-1be169fc0280	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 [MYLAN PHARMACEUTICALS INC.]	16
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
SODIUM ALGINATE	INACTIVE INGREDIENT	C269C4G2ZQ	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
PAROXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	3I3T11UD2S	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3

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	21b3b8a2-bfed-4945-954d-6a42ea61888f	3
1738805	PARoxetine HCl 25 MG 24HR Extended Release Oral Tablet	PSN	21b3b8a2-bfed-4945-954d-6a42ea61888f	3
1738803	24 HR paroxetine hydrochloride 12.5 MG Extended Release Oral Tablet	SCD	21b3b8a2-bfed-4945-954d-6a42ea61888f	3
1738805	24 HR paroxetine hydrochloride 25 MG Extended Release Oral Tablet	SCD	21b3b8a2-bfed-4945-954d-6a42ea61888f	3
1738803	paroxetine hydrochloride 12.5 MG 24 HR Extended Release Oral Tablet	SY	21b3b8a2-bfed-4945-954d-6a42ea61888f	3
1738805	paroxetine hydrochloride 25 MG 24 HR Extended Release Oral Tablet	SY	21b3b8a2-bfed-4945-954d-6a42ea61888f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-2004-93	00378200493	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0378-2004-93)	2008-05-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Paroxetine Hydrochloride	Mylan Pharmaceuticals Inc.	2021-10-20	HUMAN PRESCRIPTION DRUG LABEL	24
Paroxetine Hydrochloride - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2011-05-17	HUMAN PRESCRIPTION DRUG LABEL	3