Quick answers
- What is Clozapine used for?
- The FDA-approved label (Clozaril, HLS Therapeutics (USA), Inc., June 6, 2025) says: “CLOZARIL is an atypical antipsychotic indicated for: • Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, CLOZARIL should be used only in patients who have failed to respond adequately to standard antipsychotic treatment • Reducing the risk of recurrent suicidal …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Clozapine have a boxed warning?
- Yes. The FDA label for Clozaril has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Clozapine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Clozapine been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started June 12, 2020 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Clozapine?
- 12 companies list prescription products of Clozapine in the FDA NDC Directory, including Aurobindo Pharma Limited, Mylan Pharmaceuticals Inc. and Teva Pharmaceuticals USA, Inc..
What Clozapine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CLOZARIL is an atypical antipsychotic indicated for: • Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, CLOZARIL should be used only in patients who have failed to respond adequately to standard antipsychotic treatment • Reducing the risk of recurrent suicidal …
— FDA label: Clozaril, HLS Therapeutics (USA), Inc., effective June 6, 2025. Read the full label on DailyMed →
The FDA has 16 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. Read it on the full label →
16 of 16 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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 |
|---|---|---|
| clozapine 100 mg tablet | Generic | $0.5737 per tablet |
| clozapine 100 mg tablet | Brand: Clozaril | $16.77 per tablet |
| clozapine 100 mg tablet, orally disintegrating | Generic | $4.20 per tablet |
| clozapine 150 mg tablet, orally disintegrating | Generic | $16.51 per tablet |
| clozapine 200 mg tablet | Generic | $0.9532 per tablet |
| clozapine 200 mg tablet, orally disintegrating | Generic | $20.95 per tablet |
| clozapine 25 mg tablet | Generic | $0.2332 per tablet |
| clozapine 25 mg tablet | Brand: Clozaril | $6.54 per tablet |
| clozapine 25 mg tablet, orally disintegrating | Generic | $1.63 per tablet |
| clozapine 50 mg tablet | Generic | $0.5135 per tablet |
NADAC list of November 4, 2026; these prices took effect between June 1, 2026 and 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.
- Aurobindo Pharma Limited9 products
- Mylan Pharmaceuticals Inc.8 products
- Teva Pharmaceuticals USA, Inc.5 products
- Mylan Institutional Inc.4 products
- American Health Packaging4 products
- Major Pharmaceuticals4 products
- Safecor Health LLC4 products
- NorthStar Rx LLC4 products
- Accord Healthcare Inc.2 products
- HLS Therapeutics (USA), Inc.2 products
- Cardinal Health 107, LLC1 product
- TruPharma, LLC1 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 |
|---|---|---|---|
| NDA019758 CLOZARIL | Heritage Life | September 26, 1989 | 83, latest June 13, 2025 2025: REMS · 2025: Labeling · 2024: Labeling |
| NDA203479 VERSACLOZ | Douglas Pharms | February 6, 2013 | 18, latest June 13, 2025 2025: REMS · 2025: Labeling · 2023: Labeling |
Generic approvals (6)
- ANDA075417Mylan · May 27, 1999
- ANDA201824Mylan · September 15, 2015
- ANDA090308Barr Labs Inc · November 25, 2015
- ANDA202873Accord Hlthcare · November 25, 2015
- ANDA206433Aurobindo Pharma · November 29, 2016
- ANDA212923Aurobindo Pharma · December 12, 2024
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.
-
June 12, 2020 · Class II · Terminated · D-1370-2020
Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-846-05 — Aurobindo Pharma USA Inc.
-
September 21, 2018 · Class II · Terminated · D-0001-2019
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5416-01 Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed wit — Teva Pharmaceuticals USA
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) — Clozaril, HLS Therapeutics (USA), Inc., effective June 6, 2025; 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 →