Quick answers
- What is Asenapine used for?
- The FDA-approved label (Saphris, Allergan, Inc., January 31, 2025) says: “INDICATIONS AN D USAGE SAPHRIS is indicated for: Schizophrenia in adults […] Bipolar I disorder […] • Acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age • Adjunctive treatment to lithium or valproate in adults • Maintenance monotherapy treatment in adults SAPHRIS is an atypical antipsychotic indicated for …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Asenapine have a boxed warning?
- Yes. The FDA label for Saphris 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 Asenapine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Asenapine been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started April 19, 2021 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Asenapine?
- 7 companies list prescription products of Asenapine in the FDA NDC Directory, including Breckenridge Pharmaceutical, Inc., MSN Laboratories Private Limited and Allergan, Inc..
What Asenapine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INDICATIONS AN D USAGE SAPHRIS is indicated for: Schizophrenia in adults […] Bipolar I disorder […] • Acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age • Adjunctive treatment to lithium or valproate in adults • Maintenance monotherapy treatment in adults SAPHRIS is an atypical antipsychotic indicated for …
— FDA label: Saphris, Allergan, Inc., effective January 31, 2025. Read the full label on DailyMed →
The FDA has 4 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 →
4 of 4 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 |
|---|---|---|
| asenapine 10 mg tablet | Generic | $2.36 per tablet |
| asenapine 2.5 mg tablet | Generic | $3.10 per tablet |
| asenapine 3.8 mg/d film, extended release | Brand: Secuado | $49.11 per unit |
| asenapine 5 mg tablet | Generic | $2.09 per tablet |
| asenapine 5.7 mg/d film, extended release | Brand: Secuado | $49.05 per unit |
| asenapine 7.6 mg/d film, extended release | Brand: Secuado | $48.83 per unit |
| asenapine maleate 10 mg tablet | Generic | $2.36 per tablet |
| asenapine maleate 10 mg tablet | Brand: Saphris | $21.18 per tablet |
| asenapine maleate 2.5 mg tablet | Generic | $3.10 per tablet |
| asenapine maleate 2.5 mg tablet | Brand: Saphris | $21.00 per tablet |
| asenapine maleate 5 mg tablet | Generic | $2.09 per tablet |
| asenapine maleate 5 mg tablet | Brand: Saphris | $21.16 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.
- Breckenridge Pharmaceutical, Inc.5 products
- MSN Laboratories Private Limited5 products
- Allergan, Inc.3 products
- Alembic Pharmaceuticals Limited3 products
- Alembic Pharmaceuticals Inc.3 products
- Noven Therapeutics, LLC3 products
- Sigmapharm Laboratories, LLC2 products
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 |
|---|---|---|---|
| NDA022117 SAPHRIS | Abbvie | August 13, 2009 | 18, latest January 22, 2025 2025: Labeling · 2017: Labeling · 2017: Efficacy |
| NDA212268 SECUADO | Hisamitsu | October 11, 2019 | 1, latest January 22, 2025 2025: Labeling |
Generic approvals (3)
- ANDA205960Breckenridge · December 10, 2020
- ANDA206098Alembic · December 10, 2020
- ANDA206107Sigmapharm Labs LLC · December 10, 2020
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 19, 2021 · Class III · Terminated · D-0379-2021
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10. — SigmaPharm Laboratories LLC
-
April 19, 2021 · Class III · Terminated · D-0380-2021
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10 — SigmaPharm Laboratories LLC
-
May 18, 2017 · Class II · Terminated · D-0880-2017
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx only, Black Cherry Flavor, Manufactured by: Catalent UK Swindon, Zydis Ltd, Blagrove, Swindon, Wilshire SN5 BRU, UK Distributed by Forest Pharmac — Forest Laboratories, LLC
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) — Saphris, Allergan, Inc., effective January 31, 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 →