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PAXIL

paroxetine hydrochloride · Tablet, Film Coated

Prescription NDA TE AB RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
PAXIL
Generic name
paroxetine hydrochloride
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
Apotex Corp
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
4
Packages
4
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Paroxetine Hydrochloride 10 mg/1 1738495 View
Paroxetine Hydrochloride 20 mg/1 1738495 View
Paroxetine Hydrochloride 30 mg/1 1738495 View
Paroxetine Hydrochloride 40 mg/1 1738495 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
8

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Serotonin Reuptake Inhibitor [EPC] EPC All 51 members
Serotonin Uptake Inhibitors [MoA] MoA All 73 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
020031
Application type
NDA · New Drug Application
Approval date
December 29, 1992
Sponsor
APOTEX
Products on application
5
Submissions recorded
64
Products approved under application 020031.
Product Trade name Form Strength Ingredient Status TE Flags
020031-001 PAXIL TABLET PAROXETINE HYDROCHLORIDE Prescription AB RLD
020031-002 PAXIL TABLET PAROXETINE HYDROCHLORIDE Prescription AB RLD
020031-003 PAXIL TABLET PAROXETINE HYDROCHLORIDE Prescription AB RLD
020031-004 PAXIL TABLET PAROXETINE HYDROCHLORIDE Discontinued —
020031-005 PAXIL TABLET PAROXETINE HYDROCHLORIDE Prescription AB RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 020031.
Type No. Action Status Date Review
Supplement 83 Labeling Approved November 26, 2024 Standard
Supplement 82 Labeling Approved August 18, 2023 Standard
Supplement 79 Labeling Approved September 20, 2021 901 Required
Supplement 77 Labeling Approved February 6, 2021 Standard
Supplement 74 Labeling Approved January 4, 2017 901 Required
Supplement 71 Labeling Approved July 18, 2014 901 Required
Supplement 67 Labeling Approved December 18, 2012 Standard
Supplement 68 Labeling Approved April 10, 2012 Standard
Supplement 66 Labeling Approved July 8, 2011 Standard
Supplement 58 Labeling Approved July 8, 2011 Standard
Supplement 69 Labeling Approved March 21, 2011 Standard
Supplement 65 Labeling Approved March 21, 2011 Unknown
Supplement 62 Labeling Approved March 21, 2011 Standard
Supplement 63 Labeling Approved October 27, 2010 Standard
Supplement 59 Labeling Approved August 7, 2009 Standard
Supplement 61 Labeling Approved January 30, 2009 Standard
Supplement 60 Labeling Approved October 31, 2008 Standard
Supplement 53 Labeling Approved August 2, 2007 Standard
Supplement 55 Labeling Approved August 22, 2006 Standard
Supplement 54 Labeling Approved August 22, 2006 Standard
Supplement 49 Labeling Approved August 22, 2006 Standard
Supplement 46 Labeling Approved March 9, 2006 Standard
Supplement 52 Labeling Approved February 6, 2006 Standard
Supplement 51 Labeling Approved February 6, 2006 Standard
Supplement 48 Labeling Approved February 6, 2006 Standard
Supplement 42 Labeling Approved July 13, 2005 Standard
Supplement 45 Labeling Approved January 12, 2005 Standard
Supplement 43 Labeling Approved May 21, 2004 Standard
Supplement 40 Labeling Approved April 8, 2004 Standard
Supplement 39 Labeling Approved April 8, 2004 Standard
Supplement 35 Efficacy Approved October 2, 2002 Standard
Supplement 29 Efficacy Approved December 14, 2001 Standard
Supplement 33 Manufacturing (CMC) Approved May 22, 2001 Standard
Supplement 34 Manufacturing (CMC) Approved April 30, 2001 Standard
Supplement 32 Manufacturing (CMC) Approved April 30, 2001 Standard
Supplement 26 Efficacy Approved April 13, 2001 Standard
Supplement 31 Labeling Approved February 15, 2001 Standard
Supplement 30 Labeling Approved September 28, 2000 Standard
Supplement 28 Manufacturing (CMC) Approved September 21, 2000 Standard
Supplement 27 Manufacturing (CMC) Approved September 20, 2000 Standard
Supplement 25 Manufacturing (CMC) Approved May 17, 2000 Standard
Supplement 23 Efficacy Approved May 11, 1999 Standard
Supplement 22 Manufacturing (CMC) Approved February 19, 1998 Standard
Supplement 21 Manufacturing (CMC) Approved February 19, 1998 Standard
Supplement 20 Manufacturing (CMC) Approved December 16, 1997 Standard
Supplement 19 Manufacturing (CMC) Approved July 22, 1997 Standard
Supplement 18 Manufacturing (CMC) Approved July 14, 1997 Standard
Supplement 13 Manufacturing (CMC) Approved June 24, 1997 Standard
Supplement 17 Labeling Approved May 19, 1997 Standard
Supplement 16 Manufacturing (CMC) Approved December 13, 1996 Standard
Supplement 15 Labeling Approved October 17, 1996 Standard
Supplement 12 Manufacturing (CMC) Approved July 11, 1996 Standard
Supplement 11 Manufacturing (CMC) Approved July 2, 1996 Standard
Supplement 9 Efficacy Approved May 7, 1996 Standard
Supplement 7 Efficacy Approved May 7, 1996 Standard
Supplement 10 Manufacturing (CMC) Approved March 5, 1996 Standard
Supplement 6 Manufacturing (CMC) Approved May 10, 1995 Standard
Supplement 8 Labeling Approved February 23, 1995 Standard
Supplement 5 Labeling Approved February 23, 1995 Standard
Supplement 3 Labeling Approved February 23, 1995 Standard

Review documents

  • 0 · Supplement · December 3, 2024
  • 0 · Supplement · December 2, 2024
  • 0 · Supplement · December 2, 2024
  • 0 · Supplement · November 16, 2023
  • 0 · Supplement · October 1, 2021
  • 0 · Supplement · September 30, 2021
  • 0 · Supplement · September 23, 2021
  • 0 · Supplement · February 11, 2021
  • 0 · Supplement · February 9, 2021
  • 0 · Supplement · January 13, 2017
  • 0 · Supplement · January 6, 2017
  • 0 · Supplement · July 29, 2014
  • 0 · Supplement · July 23, 2014
  • 0 · Supplement · January 16, 2014
  • 0 · Supplement · December 31, 2012
  • 0 · Supplement · December 21, 2012
  • 0 · Supplement · April 17, 2012
  • 0 · Supplement · April 12, 2012
  • 0 · Supplement · July 12, 2011
  • 0 · Supplement · July 12, 2011
  • 0 · Supplement · July 12, 2011
  • 0 · Supplement · July 12, 2011
  • 0 · Supplement · March 28, 2011
  • 0 · Supplement · March 28, 2011
  • 0 · Supplement · March 28, 2011
  • 0 · Supplement · March 24, 2011
  • 0 · Supplement · March 24, 2011
  • 0 · Supplement · March 24, 2011
  • 0 · Supplement · November 2, 2010
  • 0 · Supplement · October 28, 2010

Adverse event reports

Source: openFDA FAERS
41,104
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: PAROXETINE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
60505-4517-3 60505-4517 Apotex Corp 30 TABLET, FILM COATED in 1 BOTTLE (60505-4517-3) March 11, 2019
60505-4518-3 60505-4518 Apotex Corp 30 TABLET, FILM COATED in 1 BOTTLE (60505-4518-3) March 11, 2019
60505-4519-3 60505-4519 Apotex Corp 30 TABLET, FILM COATED in 1 BOTTLE (60505-4519-3) March 11, 2019
60505-4520-3 60505-4520 Apotex Corp 30 TABLET, FILM COATED in 1 BOTTLE (60505-4520-3) March 11, 2019
60505-4517 60505-4517 Apotex Corp — March 11, 2019
60505-4518 60505-4518 Apotex Corp — March 11, 2019
60505-4519 60505-4519 Apotex Corp — March 11, 2019
60505-4520 60505-4520 Apotex Corp — March 11, 2019

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.