Quick answers
- What is Olanzapine used for?
- The FDA-approved label (Olanzapine Intramuscular, UBI Pharma Inc., March 23, 2026) says: “Olanzapine is an atypical antipsychotic indicated: As Olanzapine for Injection for the: Treatment of acute agitation associated with schizophrenia and bipolar I mania. Efficacy was established in three 1-day trials in adults. 1.4 Olanzapine for Injection …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Olanzapine have a boxed warning?
- Yes. The FDA label for Olanzapine Intramuscular has a boxed warning (“WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Olanzapine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Olanzapine been recalled?
- FDA enforcement reports list 4 recalls of products of this medicine; the newest started August 27, 2026 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Olanzapine?
- 44 companies list prescription products of Olanzapine in the FDA NDC Directory, including Remedyrepack Inc., Coupler LLC and Bryant Ranch Prepack.
What Olanzapine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Olanzapine is an atypical antipsychotic indicated: As Olanzapine for Injection for the: Treatment of acute agitation associated with schizophrenia and bipolar I mania. Efficacy was established in three 1-day trials in adults. 1.4 Olanzapine for Injection …
— FDA label: Olanzapine Intramuscular, UBI Pharma Inc., effective March 23, 2026. Read the full label on DailyMed →
The FDA has 93 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
. Read it on the full label →
93 of 93 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet, orally disintegrating · Tablet · Injection, powder, for solution · Injection, powder, lyophilized, for solution |
|---|---|
| Route | Oral · Intramuscular |
| Prescription products | 219 in the FDA NDC Directory |
| Brand names | Zyprexa, Zyprexa Zydis, Olanzapine Intramuscular, Zyprexa Intramuscular |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| olanzapine 10 mg injection, powder, lyophilized, for solution | Generic | $20.85 per unit |
| olanzapine 10 mg tablet | Generic | $0.1086 per tablet |
| olanzapine 10 mg tablet, film coated | Generic | $0.1086 per tablet |
| olanzapine 10 mg tablet, orally disintegrating | Generic | $0.3796 per tablet |
| olanzapine 10 mg/2 mL injection, powder, for solution | Generic | $20.85 per unit |
| olanzapine 10 mg/2 mL injection, powder, lyophilized, for solution | Generic | $20.85 per unit |
| olanzapine 15 mg tablet | Generic | $0.1378 per tablet |
| olanzapine 15 mg tablet, film coated | Generic | $0.1378 per tablet |
| olanzapine 15 mg tablet, orally disintegrating | Generic | $0.6573 per tablet |
| olanzapine 2.5 mg tablet | Generic | $0.0809 per tablet |
| olanzapine 2.5 mg tablet, film coated | Generic | $0.0809 per tablet |
| olanzapine 20 mg tablet | Generic | $0.1552 per tablet |
| olanzapine 20 mg tablet | Brand: Zyprexa | $49.68 per tablet |
| olanzapine 20 mg tablet, film coated | Generic | $0.1552 per tablet |
| olanzapine 20 mg tablet, orally disintegrating | Generic | $0.7464 per tablet |
| olanzapine 5 mg tablet | Generic | $0.0882 per tablet |
| olanzapine 5 mg tablet | Brand: Zyprexa | $16.62 per tablet |
| olanzapine 5 mg tablet, film coated | Generic | $0.0882 per tablet |
| olanzapine 5 mg tablet, orally disintegrating | Generic | $0.2967 per tablet |
| olanzapine 7.5 mg tablet | Generic | $0.0986 per tablet |
| olanzapine 7.5 mg tablet, film coated | Generic | $0.0986 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Remedyrepack Inc.15 products
- Coupler LLC14 products
- Bryant Ranch Prepack11 products
- H2-Pharma, LLC11 products
- HEC Pharm USA Inc.10 products
- Torrent Pharmaceuticals Limited10 products
- Macleods Pharmaceuticals Limited10 products
- Golden State Medical Supply, Inc.10 products
- Apotex Corp.10 products
- Aurobindo Pharma Limited10 products
- Proficient Rx LP7 products
- NorthStar RxLLC7 products
- Qilu Pharmaceutical Co., Ltd.7 products
- Cadila Pharmaceuticals Limited6 products
- Ascend Laboratories, LLC6 products
- Modavar Pharmaceuticals LLC6 products
- NCS HealthCare of KY, LLC dba Vangard Labs5 products
- American Health Packaging5 products
- Major Pharmaceuticals4 products
- Teva Pharmaceuticals USA, Inc.4 products
- Strides Pharma Science Limited4 products
- Bionpharma Inc.4 products
- Lannett Company, Inc.4 products
- Jubilant Cadista Pharmacuticals Inc.4 products
- Dr. Reddy's Laboratories Limited4 products
- Dr.Reddy's Laboratories Ltd.3 products
- Cardinal Health 107, LLC3 products
- Dr. Reddy's Laboratories Inc.3 products
- Preferred Pharmaceuticals Inc.3 products
- Unit Dose Solutions, Inc.2 products
- Direct_Rx2 products
- PD-Rx Pharmaceuticals, Inc.2 products
- Sandoz Inc2 products
- Camber Pharmaceuticals, Inc.1 product
- PAI Holdings, LLC dba PAI Pharma1 product
- Hikma Pharmaceuticals USA Inc.1 product
- Glenmark Pharmaceuticals Inc., USA1 product
- American Regent, Inc.1 product
- Eugia US LLC1 product
- Aphena Pharma Solutions - Tennessee, LLC1 product
- UBI Pharma Inc.1 product
- Anthea Pharma Private Limited1 product
- XGen Pharmaceuticals DJB, Inc.1 product
- Redpharm Drug1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020592 ZYPREXA | Cheplapharm | September 30, 1996 | 47, latest January 30, 2026 2026: Labeling · 2025: Labeling · 2020: Labeling |
| NDA021086 ZYPREXA ZYDIS | Cheplapharm | April 6, 2000 | 30, latest January 30, 2026 2026: Labeling · 2025: Labeling · 2020: Labeling |
| NDA021253 ZYPREXA | Cheplapharm | March 29, 2004 | 27, latest January 30, 2026 2026: Labeling · 2025: Labeling · 2020: Labeling |
Generic approvals (27)
- ANDA076133DR Reddys Labs Ltd · October 24, 2011
- ANDA076534DR Reddys Labs Ltd · October 24, 2011
- ANDA078109Strides Pharma Intl · October 24, 2011
- ANDA091265Apotex Inc · October 24, 2011
- ANDA201588Sandoz Inc · October 24, 2011
- ANDA091415Torrent · October 25, 2011
- ANDA077243Barr Labs Inc · January 30, 2012
- ANDA201741Am Regent · March 20, 2012
- ANDA076255DR Reddys Labs Ltd · April 23, 2012
- ANDA090798Apotex Inc · April 23, 2012
- ANDA091434Torrent Pharms Ltd · April 23, 2012
- ANDA202050Aurobindo Pharma Ltd · April 23, 2012
- ANDA200221Jubilant Generics · September 12, 2012
- ANDA203708Aurobindo Pharma Ltd · May 15, 2014
- ANDA202862Macleods Pharms Ltd · August 15, 2014
- ANDA203044Macleods Pharms · February 20, 2015
- ANDA202937Orbion Pharms · March 2, 2015
- ANDA202295Alkem Labs Ltd · October 20, 2015
- ANDA204319Qilu · January 27, 2016
- ANDA208146Hec Pharm · July 3, 2018
- ANDA206238Sunshine · November 19, 2018
- ANDA210968Eugia Pharma · October 22, 2020
- ANDA210022Cadila Pharms Ltd · February 24, 2023
- ANDA217466Aspiro · March 22, 2023
- ANDA218116Qilu · May 16, 2025
- ANDA211072Ubi · June 11, 2025
- ANDA220323Anthea Pharma · March 5, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 27, 2026 · Class III · Ongoing · D-0867-2026
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-068-07. — Macleods Pharmaceuticals Limited
-
November 25, 2024 · Class II · Ongoing · D-0154-2025
Failed Impurities/Degradation Specifications
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmac — Macleods Pharmaceuticals Ltd
-
February 16, 2022 · Class II · Terminated · D-0639-2022
cGmp Deviations
Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, HImachal Pradesh, India, NDC 33342-070-0 — Macleods Pharma Usa Inc
-
October 13, 2016 · Class III · Terminated · D-0468-2017
Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.
Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-163-30 — Dr. Reddy's Laboratories, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Olanzapine Intramuscular, UBI Pharma Inc., effective March 23, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →