PAXIL

Product NDC: 71335-0572
Requested package NDC: 71335-0572-2
11-digit product format: 713350572
Labeler code: 71335
Product ID: 71335-0572_ba697f67-8406-4416-bdfa-e1b5ce6a9a68
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: 2011-01-01
Marketing end: 0000-00-00
Substance: PAROXETINE HYDROCHLORIDE ANHYDROUS
Active strength: 25 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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	71335-0572	71335-0572-2	D	Discontinued by firm		2026-07-31

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

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.

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
2026-08-01 22:54:32	2026-06	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N020936-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020936-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020936-003	AB	1	`a50c72e98297…`

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 · 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
3I3T11UD2S	PAROXETINE HYDROCHLORIDE ANHYDROUS	78246-49-8	PAROXETINE HYDROCHLORIDE ANHYDROUS

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0572-2	71335057202	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0572-2)	2011-01-01	0000-00-00	No	No	Current