FDA label
What is asenapine used for?
The FDA-approved uses of asenapine, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Asenapine sublingual tablets are indicated for: Schizophrenia in adults; Bipolar I disorder.”
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Asenapine Maleate, tablet
Indications and Usage, quoted from the label by Breckenridge Pharmaceutical, Inc. (ANDA205960). Cross-references to other label sections are left out.
Asenapine sublingual tablets are 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
Source: DailyMed label, set id f5cd9abb-40e3-4cb5-a1b2-40cdba8a1c7e, version 7, effective July 17, 2026. NDC 51991-358, one of 10 listings for this product.
Asenapine, tablet
Indications and Usage, quoted from the label by Sigmapharm Laboratories, LLC (ANDA206107). Cross-references to other label sections are left out.
Asenapine sublingual tablet(s) is indicated for:
- Bipolar I disorder
- Adjunctive treatment to lithium or valproate in adults
Source: DailyMed label, set id 3512687b-d1c7-45c4-8822-3a2ad53575a5, version 11, effective November 25, 2025. NDC 42794-016, one of 8 listings for this product.
Questions
What is asenapine used for?
The FDA label says: “Asenapine sublingual tablets are indicated for: Schizophrenia in adults; Bipolar I disorder.”
What drug class is asenapine?
FDA lists asenapine in the Atypical Antipsychotic established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.