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Zyprexa

Olanzapine · 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
Zyprexa
Generic name
Olanzapine
Dosage form
Tablet
Route
Oral
Marketing category
NDA · NDA
Labeler
H2-Pharma LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
6
NDC product codes
6
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
Olanzapine 10 mg/1 314154 View
Olanzapine 15 mg/1 314154 View
Olanzapine 2.5 mg/1 314154 View
Olanzapine 20 mg/1 314154 View
Olanzapine 5 mg/1 314154 View
Olanzapine 7.5 mg/1 314154 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
12

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
020592
Application type
NDA · New Drug Application
Approval date
September 30, 1996
Sponsor
CHEPLAPHARM
Products on application
6
Submissions recorded
48
Products approved under application 020592.
Product Trade name Form Strength Ingredient Status TE Flags
020592-001 ZYPREXA TABLET OLANZAPINE Prescription AB RLD
020592-002 ZYPREXA TABLET OLANZAPINE Prescription AB RLD RS
020592-003 ZYPREXA TABLET OLANZAPINE Prescription AB RLD
020592-004 ZYPREXA TABLET OLANZAPINE Prescription AB RLD
020592-005 ZYPREXA TABLET OLANZAPINE Prescription AB RLD
020592-006 ZYPREXA TABLET OLANZAPINE 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 020592.
Type No. Action Status Date Review
Supplement 79 Labeling Approved January 30, 2026 Standard
Supplement 77 Labeling Approved January 22, 2025 Standard
Supplement 74 Labeling Approved April 23, 2020 Standard
Supplement 75 Labeling Approved April 21, 2020 901 Required
Supplement 72 Labeling Approved October 22, 2019 Standard
Supplement 71 Labeling Approved March 27, 2018 Standard
Supplement 69 Labeling Approved February 23, 2017 901 Required
Supplement 68 Labeling Approved February 23, 2017 Standard
Supplement 67 Labeling Approved October 6, 2016 901 Required
Supplement 64 Labeling Approved July 23, 2015 Standard
Supplement 62 Labeling Approved December 19, 2014 Standard
Supplement 66 Manufacturing (CMC) Approved October 25, 2013 Standard
Supplement 65 Manufacturing (CMC) Approved October 21, 2013 Standard
Supplement 63 Efficacy Approved July 26, 2013 Standard
Supplement 61 REMS Approved June 21, 2011 N/A
Supplement 60 REMS Approved June 21, 2011 N/A
Supplement 57 Labeling Approved December 1, 2010 901 Required
Supplement 55 Labeling Approved May 27, 2010 Unknown
Supplement 53 Labeling Approved May 27, 2010 Unknown
Supplement 52 Labeling Approved January 27, 2010 Unknown
Supplement 41 Efficacy Approved December 4, 2009 Priority
Supplement 40 Efficacy Approved December 4, 2009 Priority
Supplement 51 Labeling Approved August 31, 2009 901 Required
Supplement 39 Efficacy Approved March 19, 2009 Priority
Supplement 49 Labeling Approved August 14, 2008 Standard
Supplement 43 Labeling Approved July 6, 2007 Standard
Supplement 42 Labeling Approved July 6, 2007 Standard
Supplement 38 Labeling Approved November 29, 2006 Standard
Supplement 29 Labeling Approved August 25, 2006 Standard
Supplement 35 Labeling Approved February 23, 2006 Standard
Supplement 32 Labeling Approved February 16, 2006 Standard
Supplement 27 Labeling Approved February 16, 2006 Standard
Supplement 34 Labeling Approved September 13, 2005 Standard
Supplement 26 Labeling Approved August 3, 2005 Standard
Supplement 20 Labeling Approved June 29, 2005 Standard
Supplement 19 Efficacy Approved January 14, 2004 Standard
Supplement 18 Efficacy Approved July 10, 2003 Standard
Supplement 16 Manufacturing (CMC) Approved January 22, 2002 Standard
Supplement 14 Manufacturing (CMC) Approved March 13, 2001 Standard
Supplement 11 Efficacy Approved November 9, 2000 Standard
Supplement 6 Efficacy Approved March 17, 2000 Standard
Supplement 10 Labeling Approved January 11, 1999 Standard
Supplement 7 Manufacturing (CMC) Approved March 23, 1998 Standard
Supplement 5 Manufacturing (CMC) Approved December 4, 1997 Standard
Supplement 4 Manufacturing (CMC) Approved September 9, 1997 Standard
Supplement 3 Manufacturing (CMC) Approved April 18, 1997 Standard
Supplement 1 Manufacturing (CMC) Approved February 19, 1997 Standard
Original application 1 Type 1 - New Molecular Entity Approved September 30, 1996 Standard

Review documents

  • 0 · Supplement · February 5, 2026
  • 0 · Supplement · February 3, 2026
  • 0 · Supplement · January 30, 2026
  • 0 · Supplement · February 7, 2025
  • 0 · Supplement · February 5, 2025
  • 0 · Supplement · April 24, 2020
  • 0 · Supplement · April 24, 2020
  • 0 · Supplement · April 22, 2020
  • 0 · Supplement · April 22, 2020
  • 0 · Supplement · October 24, 2019
  • 0 · Supplement · October 23, 2019
  • 0 · Supplement · March 29, 2018
  • 0 · Supplement · March 28, 2018
  • 0 · Supplement · March 2, 2017
  • 0 · Supplement · March 2, 2017
  • 0 · Supplement · February 27, 2017
  • 0 · Supplement · February 27, 2017
  • 0 · Supplement · October 14, 2016
  • 0 · Supplement · October 7, 2016
  • 0 · Supplement · July 24, 2015
  • 0 · Supplement · January 9, 2015
  • 0 · Supplement · December 23, 2014
  • 0 · Supplement · July 30, 2013
  • 0 · Supplement · July 30, 2013
  • 0 · Supplement · March 16, 2012
  • 0 · Supplement · March 16, 2012
  • 0 · Supplement · March 16, 2012
  • 0 · Supplement · March 16, 2012
  • 0 · Supplement · January 27, 2012
  • 0 · Original application · December 22, 2011

Adverse event reports

Source: openFDA FAERS
109,181
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: OLANZAPINE. 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
61269-630-30 61269-630 H2-Pharma LLC 30 TABLET in 1 BOTTLE (61269-630-30) June 23, 1997
61269-631-30 61269-631 H2-Pharma LLC 30 TABLET in 1 BOTTLE (61269-631-30) October 1, 1996
61269-632-30 61269-632 H2-Pharma LLC 30 TABLET in 1 BOTTLE (61269-632-30) October 1, 1996
61269-633-30 61269-633 H2-Pharma LLC 30 TABLET in 1 BOTTLE (61269-633-30) October 1, 1996
61269-634-30 61269-634 H2-Pharma LLC 30 TABLET in 1 BOTTLE (61269-634-30) January 10, 2000
61269-635-30 61269-635 H2-Pharma LLC 30 TABLET in 1 BOTTLE (61269-635-30) March 1, 2001
61269-630 61269-630 H2-Pharma LLC — June 23, 1997
61269-631 61269-631 H2-Pharma LLC — October 1, 1996
61269-632 61269-632 H2-Pharma LLC — October 1, 1996
61269-633 61269-633 H2-Pharma LLC — October 1, 1996
61269-634 61269-634 H2-Pharma LLC — January 10, 2000
61269-635 61269-635 H2-Pharma LLC — March 1, 2001

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.