PAROXETINE HYDROCHLORIDE

Product NDC: 63629-4615
11-digit product format: 636294615
Labeler code: 63629
Product ID: 63629-4615_4c7ed1cf-75c6-461d-8bda-17955dadb43c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: paroxetine hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: NDA020936
Marketing category: NDA
Marketing start: 2010-09-13
Marketing end: 0000-00-00
Substance: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength: 13 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	63629-4615		D	Discontinued by firm	2026-08-17
excluded package	package	63629-4615	63629-4615-1	D	Discontinued by firm	2026-08-17
excluded package	package	63629-4615	63629-4615-2	D	Discontinued by firm	2026-08-17
excluded package	package	63629-4615	63629-4615-3	D	Discontinued by firm	2026-08-17
excluded package	package	63629-4615	63629-4615-4	D	Discontinued by firm	2026-08-17
excluded package	package	63629-4615	63629-4615-5	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 2 · 114 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	63629-4615-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4615-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4615-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4615-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4615-3	`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	63629-4615-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4615-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4615-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4615-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4615-3	`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	63629-4615-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4615-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4615-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4615-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4615-3	`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	63629-4615-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4615-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4615-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4615-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4615-3	`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	63629-4615-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4615-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4615-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4615-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4615-3	`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	63629-4615-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4615-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4615-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4615-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4615-3	`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	63629-4615-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4615-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4615-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4615-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4615-3	`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	63629-4615-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4615-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4615-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4615-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4615-3	`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	63629-4615-5	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-4615-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-4615-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-4615-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-4615-3	`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	63629-4615-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-4615-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-4615-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-4615-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-4615-3	`ad56d346431e…`	`cc804d4bbf1e…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020936-001	PAXIL CR	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16
N020936-002	PAXIL CR	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16
N020936-003	PAXIL CR	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N020936-001	AB
N020936-002	AB
N020936-003	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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	N020936-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020936-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020936-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020936-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020936-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020936-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020936-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020936-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020936-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020936-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020936-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020936-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020936-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020936-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020936-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020936-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020936-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020936-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020936-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020936-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020936-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020936-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020936-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020936-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020936-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020936-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020936-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020936-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020936-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020936-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020936-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020936-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020936-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020936-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020936-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020936-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020936-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020936-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020936-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020936-001	AB	1	`1e350fbaab3a…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-4615-1	2023-03-06	Paroxetine Hydrochloride Controlled-Release Tablets
63629-4615-2	2023-03-06	Paroxetine Hydrochloride Controlled-Release Tablets
63629-4615-3	2023-03-06	Paroxetine Hydrochloride Controlled-Release Tablets
63629-4615-4	2023-03-06	Paroxetine Hydrochloride Controlled-Release Tablets
63629-4615-5	2023-03-06	Paroxetine Hydrochloride Controlled-Release Tablets
63629-4615-1	2020-01-31	Paroxetine Hydrochloride Controlled-Release Tablets
63629-4615-2	2020-01-31	Paroxetine Hydrochloride Controlled-Release Tablets
63629-4615-3	2020-01-31	Paroxetine Hydrochloride Controlled-Release Tablets
63629-4615-4	2020-01-31	Paroxetine Hydrochloride Controlled-Release Tablets
63629-4615-5	2020-01-31	Paroxetine Hydrochloride Controlled-Release Tablets

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-4615-1	EA - Each	63629-4615	573af3d4-9c6c-4e95-82ac-ef3a805bf23f	1	2015-10-02
63629-4615-2	EA - Each	63629-4615	cc3acf4c-39ec-480c-9b73-d23e9376d9f8	1	2015-10-02
63629-4615-3	EA - Each	63629-4615	a34f0c15-c1e0-4219-af22-99cccf19e08c	1	2015-10-02
63629-4615-4	EA - Each	63629-4615	4a4c10a0-77bb-4c4f-891e-36e664fe3715	1	2015-10-02
63629-4615-5	EA - Each	63629-4615	a25971a9-2b67-414d-bc95-a3239199d914	1	2015-10-02

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 [BRYANT RANCH PREPACK]	1000
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PAXIL CR	PAROXETINE HYDROCHLORIDE	Apotex Corp	483bd97f-c4d0-4e23-aaa8-6334f4471e0c	2025-09-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020936 application number: NDA020936
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	Apotex Corp	087ff0d3-1761-47ea-a8c1-7c4cb679af97	2025-09-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020936 application number: NDA020936

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X2ELS050D8	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	110429-35-1	PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Paroxetine Hydrochloride Controlled-Release Tablets	Bryant Ranch Prepack	2015-04-30	HUMAN PRESCRIPTION DRUG LABEL	1000