Paroxetine

Product NDC: 57664-421
11-digit product format: 576640421
Labeler code: 57664
Product ID: 57664-421_38e34831-580e-4773-a1a8-7358fee2424e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Paroxetine
Dosage form: TABLET
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA078194
Marketing category: ANDA
Marketing start: 2007-06-29
Marketing end: 0000-00-00
Substance: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength: 10 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	57664-421		D	Discontinued by firm	2026-10-15
excluded package	package	57664-421	57664-421-08	D	Discontinued by firm	2026-10-15
excluded package	package	57664-421	57664-421-13	D	Discontinued by firm	2026-10-15
excluded package	package	57664-421	57664-421-18	D	Discontinued by firm	2026-10-15
excluded package	package	57664-421	57664-421-83	D	Discontinued by firm	2026-10-15
excluded package	package	57664-421	57664-421-99	D	Discontinued by firm	2026-10-15

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 2 · 72 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	57664-421-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57664-421-99	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57664-421-83	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57664-421-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57664-421-18	`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	57664-421-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57664-421-99	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57664-421-83	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57664-421-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57664-421-18	`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	57664-421-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57664-421-99	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57664-421-83	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57664-421-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57664-421-18	`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	57664-421-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57664-421-99	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57664-421-83	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57664-421-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57664-421-18	`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	57664-421-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57664-421-99	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57664-421-83	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57664-421-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57664-421-18	`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	57664-421-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57664-421-99	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57664-421-83	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57664-421-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57664-421-18	`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	57664-421-13	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57664-421-99	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57664-421-83	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57664-421-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57664-421-18	`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	57664-421-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57664-421-99	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57664-421-83	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57664-421-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57664-421-18	`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	57664-421-13	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57664-421-99	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57664-421-83	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57664-421-08	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57664-421-18	`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	57664-421-13	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57664-421-99	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57664-421-83	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57664-421-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57664-421-18	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A078194-001	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-06-29
A078194-002	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-06-29
A078194-003	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2007-06-29
A078194-004	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-06-29

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 5 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A078194-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-06-29	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A078194-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-06-29	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A078194-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2007-06-29	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A078194-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078194-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-06-29	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A078194-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-06-29	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A078194-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2007-06-29	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A078194-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-06-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078194-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-06-29	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078194-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-06-29	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078194-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2007-06-29	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078194-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-06-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078194-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-06-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078194-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-06-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078194-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2007-06-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078194-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-06-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A078194-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078194-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078194-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078194-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078194-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078194-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078194-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078194-004	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57664-421-13	EA - Each	57664-421	a159c85a-bedc-40f7-ae48-c7237bea5bcc	1	2013-02-13
57664-421-83	EA - Each	57664-421	dc6d3c8a-d1c4-488b-be81-0b180246613b	1	2013-02-13
57664-421-99	EA - Each	57664-421	0c8e9eef-75c7-4293-b4d5-2cc63022c8d5	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PAROXETINE HYDROCHLORIDE HEMIHYDRATE	ACTIVE INGREDIENT	X2ELS050D8	PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X2ELS050D8	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	110429-35-1	PAROXETINE HYDROCHLORIDE HEMIHYDRATE
41VRH5220H	PAROXETINE	61869-08-7	Paroxetine

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRESCRIBING INFORMATION Paroxetine Tablets, USP	Sun Pharmaceutical Industries, Inc. \| ALKALOIDA chemical company Zrt	2017-02-08	HUMAN PRESCRIPTION DRUG LABEL	8