PAXIL

Product NDC: 21695-160
11-digit product format: 216950160
Labeler code: 21695
Product ID: 21695-160_a73cf8ee-f99b-4972-8939-0d394a527134
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: paroxetine hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA020936
Marketing category: NDA
Marketing start: 2002-04-09
Marketing end: 0000-00-00
Substance: PAROXETINE HYDROCHLORIDE
Active strength: 25 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-160		I	Inactivated by FDA		2026-10-05
excluded package	package	21695-160	21695-160-30	I	Inactivated by FDA		2026-10-05

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 · 44 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	21695-160-30	`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	21695-160-30	`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	21695-160-30	`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	21695-160-30	`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	21695-160-30	`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	21695-160-30	`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	21695-160-30	`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	21695-160-30	`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	21695-160-30	`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	21695-160-30	`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	21695-160-30	`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	21695-160-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-160-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-160-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-160-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-160-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-160-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-160-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-160-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-160-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-160-30	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-160-30	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 129 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
2026-09-14 22:38:34	2026-08	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N020936-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020936-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020936-003	AB	1	`84e616aacf4f…`
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…`
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Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-160-30	2019-09-24	C162847	48780-1	934fe258-49b6-48b1-e053-8cdaa90a720a	PAXIL CR ® (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
21695-160-30	EA - Each	21695-160	e1d74a10-222e-4bb3-8ea1-d0449ddf8d26	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PAROXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	3I3T11UD2S	PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
GLYCERYL BEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PAXIL CR ® (paroxetine hydrochloride) Controlled-Release Tablets	Rebel Distributors Corp	2010-11-10	HUMAN PRESCRIPTION DRUG LABEL	1