FDA label
What is lurasidone used for?
The FDA-approved uses of lurasidone, 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: “Lurasidone hydrochloride tablet is indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia; Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression); Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated wit...”
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Lurasidone Hydrochloride, tablet, film coated
Indications and Usage, quoted from the label by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. (ANDA208058). Cross-references to other label sections are left out.
Lurasidone hydrochloride tablet is indicated for:
- Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia.
- Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression).
- Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression).
Source: DailyMed label, set id 083a1a52-5a13-4e28-8ef2-127ac4ce5b2d, version 8, effective October 16, 2026. NDC 23155-887, one of 92 listings for this product.
Questions
What is lurasidone used for?
The FDA label says: “Lurasidone hydrochloride tablet is indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia; Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression); Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated wit...”
What drug class is lurasidone?
FDA lists lurasidone 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.
More on Lurasidone
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- Atypical Antipsychotics listFDA drug class
- NDC 63402-302Lurasidone NDC record
- NDC 63402-304Lurasidone NDC record
- NDC 63402-306Lurasidone NDC record