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Geodon

ziprasidone · Capsule

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
Geodon
Generic name
ziprasidone
Dosage form
Capsule
Route
Oral
Marketing category
NDA · NDA
Labeler
ROERIG
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
8
Packages
6
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
Ziprasidone 20 mg/1 — —
Ziprasidone 40 mg/1 — —
Ziprasidone 60 mg/1 — —
Ziprasidone 80 mg/1 — —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule
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
020825
Application type
NDA · New Drug Application
Approval date
February 5, 2001
Sponsor
VIATRIS
Products on application
4
Submissions recorded
35
Products approved under application 020825.
Product Trade name Form Strength Ingredient Status TE Flags
020825-001 GEODON CAPSULE ZIPRASIDONE HYDROCHLORIDE Prescription AB RLD RS
020825-002 GEODON CAPSULE ZIPRASIDONE HYDROCHLORIDE Prescription AB RLD
020825-003 GEODON CAPSULE ZIPRASIDONE HYDROCHLORIDE Prescription AB RLD
020825-004 GEODON CAPSULE ZIPRASIDONE HYDROCHLORIDE 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 020825.
Type No. Action Status Date Review
Supplement 65 Labeling Approved January 22, 2025 Standard
Supplement 63 Efficacy Approved January 28, 2022 Standard
Supplement 62 Labeling Approved May 18, 2021 Standard
Supplement 61 Labeling Approved October 29, 2020 Standard
Supplement 58 Labeling Approved January 23, 2020 Standard
Supplement 59 Labeling Approved November 5, 2018 Standard
Supplement 56 Labeling Approved February 23, 2017 901 Required
Supplement 54 Labeling Approved August 20, 2015 Standard
Supplement 50 Manufacturing (CMC) Approved June 17, 2015 Standard
Supplement 53 Labeling Approved December 10, 2014 Standard
Supplement 49 Labeling Approved December 17, 2013 Standard
Supplement 47 Labeling Approved August 13, 2013 Standard
Supplement 41 Labeling Approved July 3, 2013 Standard
Supplement 46 Labeling Approved March 1, 2013 Standard
Supplement 38 Labeling Approved December 1, 2010 901 Required
Supplement 34 Efficacy Approved November 20, 2009 Standard
Supplement 28 Labeling Approved November 12, 2009 Standard
Supplement 35 Labeling Approved July 19, 2009 901 Required
Supplement 30 Labeling Approved August 14, 2008 Standard
Supplement 27 Labeling Approved May 16, 2008 Standard
Supplement 26 Labeling Approved October 2, 2007 Standard
Supplement 24 Labeling Approved May 24, 2007 Standard
Supplement 21 Labeling Approved March 2, 2007 Standard
Supplement 17 Labeling Approved August 17, 2005 Standard
Supplement 15 Labeling Approved August 17, 2005 Standard
Supplement 9 Efficacy Approved August 19, 2004 Standard
Supplement 12 Labeling Approved August 13, 2004 Standard
Supplement 8 Labeling Approved December 23, 2003 Standard
Supplement 5 Manufacturing (CMC) Approved June 25, 2002 Standard
Supplement 6 Labeling Approved February 15, 2002 Standard
Supplement 4 Manufacturing (CMC) Approved January 22, 2002 Standard
Supplement 1 Manufacturing (CMC) Approved June 7, 2001 Standard
Supplement 3 Manufacturing (CMC) Approved May 25, 2001 Standard
Supplement 2 Manufacturing (CMC) Approved May 25, 2001 Standard
Original application 1 Type 1 - New Molecular Entity Approved February 5, 2001 Standard

Review documents

  • 0 · Supplement · February 6, 2025
  • 0 · Supplement · February 5, 2025
  • 0 · Supplement · February 1, 2022
  • 0 · Supplement · January 31, 2022
  • 0 · Supplement · May 20, 2021
  • 0 · Supplement · May 19, 2021
  • 0 · Supplement · February 2, 2021
  • 0 · Supplement · November 2, 2020
  • 0 · Supplement · January 24, 2020
  • 0 · Supplement · January 24, 2020
  • 0 · Supplement · November 16, 2018
  • 0 · Supplement · November 6, 2018
  • 0 · Supplement · March 2, 2017
  • 0 · Supplement · February 24, 2017
  • 0 · Supplement · September 14, 2015
  • 0 · Supplement · August 24, 2015
  • 0 · Supplement · December 11, 2014
  • 0 · Supplement · December 11, 2014
  • 0 · Supplement · December 19, 2013
  • 0 · Supplement · December 19, 2013
  • 0 · Supplement · August 16, 2013
  • 0 · Supplement · August 15, 2013
  • 0 · Supplement · July 5, 2013
  • 0 · Supplement · July 5, 2013
  • 0 · Supplement · March 5, 2013
  • 0 · Supplement · March 4, 2013
  • 0 · Supplement · October 12, 2012
  • 0 · Original application · December 22, 2011
  • 0 · Supplement · December 7, 2010
  • 0 · Supplement · December 4, 2010

Adverse event reports

Source: openFDA FAERS
6,150
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: ZIPRASIDONE. 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
0049-0352-60 0049-0352 ROERIG 60 CAPSULE in 1 BOTTLE (0049-0352-60) November 8, 2021
0049-0354-60 0049-0354 ROERIG 60 CAPSULE in 1 BOTTLE (0049-0354-60) July 14, 2023
0049-0356-60 0049-0356 ROERIG 60 CAPSULE in 1 BOTTLE (0049-0356-60) November 8, 2021
0049-0358-60 0049-0358 ROERIG 60 CAPSULE in 1 BOTTLE (0049-0358-60) November 8, 2021
58151-132-91 58151-132 Viatris Specialty LLC 60 CAPSULE in 1 BOTTLE (58151-132-91) September 16, 2026
58151-134-91 58151-134 Viatris Specialty LLC 60 CAPSULE in 1 BOTTLE (58151-134-91) April 15, 2026
0049-0352 0049-0352 ROERIG — November 8, 2021
0049-0354 0049-0354 ROERIG — July 14, 2023
0049-0356 0049-0356 ROERIG — November 8, 2021
0049-0358 0049-0358 ROERIG — November 8, 2021
58151-131 58151-131 Viatris Specialty LLC — September 9, 2025
58151-132 58151-132 Viatris Specialty LLC — September 16, 2026
58151-133 58151-133 Viatris Specialty LLC — September 9, 2025
58151-134 58151-134 Viatris Specialty LLC — April 15, 2026

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.