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RISPERDAL

risperidone · Tablet

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
RISPERDAL
Generic name
risperidone
Dosage form
Tablet
Route
Oral
Marketing category
NDA · NDA
Labeler
Janssen Pharmaceuticals, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
5
NDC product codes
5
Packages
9
Data completeness
60% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Risperidone .5 mg/1 312832 View
Risperidone 1 mg/1 312832 View
Risperidone 2 mg/1 312832 View
Risperidone 3 mg/1 312832 View
Risperidone 4 mg/1 312832 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
14

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
Atypical Antipsychotic [EPC] EPC All 62 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
020272
Application type
NDA · New Drug Application
Approval date
December 29, 1993
Sponsor
JANSSEN PHARMS
Products on application
7
Submissions recorded
55
Products approved under application 020272.
Product Trade name Form Strength Ingredient Status TE Flags
020272-001 RISPERDAL TABLET RISPERIDONE Prescription AB RLD RS
020272-002 RISPERDAL TABLET RISPERIDONE Prescription AB RLD
020272-003 RISPERDAL TABLET RISPERIDONE Prescription AB RLD
020272-004 RISPERDAL TABLET RISPERIDONE Prescription AB RLD
020272-005 RISPERDAL TABLET RISPERIDONE Discontinued —
020272-007 RISPERDAL TABLET RISPERIDONE Prescription AB RLD
020272-008 RISPERDAL TABLET RISPERIDONE Prescription AB RLD

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 020272.
Type No. Action Status Date Review
Supplement 88 Labeling Approved January 22, 2025 Standard
Supplement 87 Labeling Approved December 2, 2022 Standard
Supplement 83 Labeling Approved February 12, 2021 Standard
Supplement 85 Labeling Approved February 5, 2020 901 Required
Supplement 82 Labeling Approved January 25, 2019 Standard
Supplement 80 Labeling Approved July 27, 2018 Standard
Supplement 78 Labeling Approved February 23, 2017 901 Required
Supplement 77 Labeling Approved March 1, 2016 Standard
Supplement 76 Manufacturing (CMC) Approved February 9, 2016 Priority
Supplement 73 Labeling Approved April 28, 2014 Standard
Supplement 72 Manufacturing (CMC) Approved June 13, 2013 Priority
Supplement 71 Manufacturing (CMC) Approved February 8, 2013 Priority
Supplement 65 Efficacy Approved August 2, 2012 Standard
Supplement 67 Labeling Approved March 12, 2012 Standard
Supplement 66 Labeling Approved September 24, 2011 Standard
Supplement 60 Labeling Approved September 24, 2011 Priority
Supplement 59 Labeling Approved August 24, 2011 Standard
Supplement 64 Labeling Approved June 15, 2011 Standard
Supplement 63 Labeling Approved December 1, 2010 901 Required
Supplement 62 Labeling Approved August 30, 2010 Unknown
Supplement 61 Labeling Approved August 30, 2010 Unknown
Supplement 58 Labeling Approved August 30, 2010 Unknown
Supplement 55 Labeling Approved August 30, 2010 Standard
Supplement 56 Labeling Approved July 19, 2009 901 Required
Supplement 54 Labeling Approved August 14, 2008 Standard
Supplement 47 Efficacy Approved August 22, 2007 Priority
Supplement 46 Efficacy Approved August 22, 2007 Priority
Supplement 41 Efficacy Approved October 6, 2006 Priority
Supplement 36 Efficacy Approved October 6, 2006 Priority
Supplement 42 Labeling Approved August 17, 2005 Standard
Supplement 27 Efficacy Approved December 4, 2003 Standard
Supplement 26 Efficacy Approved December 4, 2003 Standard
Supplement 35 Labeling Approved November 21, 2003 Standard
Supplement 25 Labeling Approved October 29, 2003 Standard
Supplement 33 Labeling Approved September 10, 2003 Standard
Supplement 24 Labeling Approved November 19, 2002 Standard
Supplement 23 Manufacturing (CMC) Approved July 9, 2002 Priority
Supplement 8 Efficacy Approved March 3, 2002 Standard
Supplement 20 Manufacturing (CMC) Approved October 22, 2001 Priority
Supplement 21 Manufacturing (CMC) Approved September 28, 2001 Priority
Supplement 19 Manufacturing (CMC) Approved July 20, 2001 Priority
Supplement 15 Manufacturing (CMC) Approved October 27, 1999 Priority
Supplement 9 Labeling Approved July 2, 1999 Standard
Supplement 14 Manufacturing (CMC) Approved May 10, 1999 Priority
Supplement 13 Manufacturing (CMC) Approved January 27, 1999 Priority
Supplement 12 Manufacturing (CMC) Approved October 26, 1998 Priority
Supplement 10 Manufacturing (CMC) Approved May 13, 1998 Priority
Supplement 6 Labeling Approved April 2, 1998 Standard
Supplement 7 Efficacy Approved October 17, 1997 Standard
Supplement 5 Manufacturing (CMC) Approved March 7, 1996 Priority
Supplement 4 Labeling Approved February 28, 1996 Standard
Supplement 3 Labeling Approved April 12, 1995 Standard
Supplement 2 Manufacturing (CMC) Approved December 22, 1994 Priority
Supplement 1 Labeling Approved August 24, 1994 Standard
Original application 1 Type 1 - New Molecular Entity Approved December 29, 1993 Priority

Review documents

  • 0 · Supplement · October 23, 2025
  • 0 · Supplement · October 23, 2025
  • 0 · Supplement · February 7, 2025
  • 0 · Supplement · February 5, 2025
  • 0 · Supplement · December 5, 2022
  • 0 · Supplement · December 5, 2022
  • 0 · Supplement · May 27, 2021
  • 0 · Supplement · February 17, 2021
  • 0 · Supplement · February 7, 2020
  • 0 · Supplement · February 6, 2020
  • 0 · Supplement · February 13, 2019
  • 0 · Supplement · January 28, 2019
  • 0 · Supplement · August 9, 2018
  • 0 · Supplement · July 30, 2018
  • 0 · Supplement · March 2, 2017
  • 0 · Supplement · February 24, 2017
  • 0 · Supplement · March 3, 2016
  • 0 · Supplement · March 3, 2016
  • 0 · Supplement · May 9, 2014
  • 0 · Supplement · April 29, 2014
  • 0 · Supplement · June 3, 2013
  • 0 · Supplement · June 3, 2013
  • 0 · Supplement · August 3, 2012
  • 0 · Supplement · August 3, 2012
  • 0 · Supplement · March 13, 2012
  • 0 · Original application · December 20, 2011
  • 0 · Supplement · December 14, 2011
  • 0 · Supplement · December 14, 2011
  • 0 · Supplement · September 30, 2011
  • 0 · Supplement · September 30, 2011

Adverse event reports

Source: openFDA FAERS
131,094
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: RISPERIDONE. 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
50458-300-01 50458-300 Janssen Pharmaceuticals, Inc. 10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-300-01) / 10 TABLET in 1 BLISTER PACK December 29, 1993
50458-300-06 50458-300 Janssen Pharmaceuticals, Inc. 60 TABLET in 1 BOTTLE (50458-300-06) December 29, 1993
50458-302-01 50458-302 Janssen Pharmaceuticals, Inc. 10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-302-01) / 10 TABLET in 1 BLISTER PACK December 29, 1993
50458-302-06 50458-302 Janssen Pharmaceuticals, Inc. 60 TABLET in 1 BOTTLE (50458-302-06) December 29, 1993
50458-320-01 50458-320 Janssen Pharmaceuticals, Inc. 10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-320-01) / 10 TABLET in 1 BLISTER PACK December 29, 1993
50458-320-06 50458-320 Janssen Pharmaceuticals, Inc. 60 TABLET in 1 BOTTLE (50458-320-06) December 29, 1993
50458-330-06 50458-330 Janssen Pharmaceuticals, Inc. 60 TABLET in 1 BOTTLE (50458-330-06) December 29, 1993
50458-350-01 50458-350 Janssen Pharmaceuticals, Inc. 10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-350-01) / 10 TABLET in 1 BLISTER PACK December 29, 1993
50458-350-06 50458-350 Janssen Pharmaceuticals, Inc. 60 TABLET in 1 BOTTLE (50458-350-06) December 29, 1993
50458-300 50458-300 Janssen Pharmaceuticals, Inc. — December 29, 1993
50458-302 50458-302 Janssen Pharmaceuticals, Inc. — December 29, 1993
50458-320 50458-320 Janssen Pharmaceuticals, Inc. — December 29, 1993
50458-330 50458-330 Janssen Pharmaceuticals, Inc. — December 29, 1993
50458-350 50458-350 Janssen Pharmaceuticals, Inc. — December 29, 1993

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 · 10 sections on this page.