Quick answers
- What is Loxapine used for?
- The FDA-approved label (Loxapine, Remedyrepack Inc., September 3, 2026) says: “Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Loxapine have a boxed warning?
- Yes. The FDA label for Loxapine has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Loxapine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Loxapine been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started April 17, 2012 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Loxapine?
- 8 companies list prescription products of Loxapine in the FDA NDC Directory, including Remedyrepack Inc., Lannett Company, Inc. and Actavis Pharma, Inc..
What Loxapine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.
— FDA label: Loxapine, Remedyrepack Inc., effective September 3, 2026. Read the full label on DailyMed →
The FDA has 14 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 →
14 of 14 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Aerosol, powder |
|---|---|
| Route | Oral · Respiratory (inhalation) |
| Prescription products | 25 in the FDA NDC Directory |
| Brand names | Adasuve |
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 |
|---|---|---|
| loxapine succinate 10 mg capsule | Generic | $0.4636 per capsule |
| loxapine succinate 25 mg capsule | Generic | $0.6906 per capsule |
| loxapine succinate 5 mg capsule | Generic | $0.3216 per capsule |
| loxapine succinate 50 mg capsule | Generic | $0.9084 per capsule |
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.6 products
- Lannett Company, Inc.4 products
- Actavis Pharma, Inc.4 products
- Elite Laboratories, Inc.4 products
- Coupler LLC3 products
- Chartwell RX, LLC2 products
- Proficient Rx LP1 product
- Alexza Pharmaceuticals, Inc.1 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 |
|---|---|---|---|
| NDA022549 ADASUVE | Nova Pneuma | December 21, 2012 | 5, latest January 27, 2022 2022: Labeling · 2021: Labeling · 2017: Labeling |
Generic approvals (6)
- ANDA072062Watson Labs · June 15, 1988
- ANDA072204Watson Labs · June 15, 1988
- ANDA072205Watson Labs · June 15, 1988
- ANDA072206Watson Labs · June 15, 1988
- ANDA076868Elite Labs Inc · August 4, 2005
- ANDA090695Lannett Co Inc · September 26, 2011
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.
-
April 17, 2012 · Class III · Terminated · D-1402-2012
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01 — Watson Laboratories Inc
-
April 17, 2012 · Class III · Terminated · D-1401-2012
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0371-01 — Watson Laboratories Inc
-
April 17, 2012 · Class III · Terminated · D-1400-2012
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only. NDC # 0591-0370-01 — Watson 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
| RxCUI (RxNorm) | 311385, 311386, 314075, 314078 |
|---|---|
| SPL set ID of the quoted label | ce8c5a31-7600-4525-a0c7-b3adc9ec2977 |
| FDA labels (SPL) | 14 |
| FDA applications | NDA022549, 6 ANDA |
| Active ingredients (FDA) | LOXAPINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Loxapine, Remedyrepack Inc., effective September 3, 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 →