FDA label
What is Aristada used for?
Aristada contains aripiprazole lauroxil. The FDA-approved uses below are 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: “ARISTADA is indicated for the treatment of schizophrenia in adults [see Clinical Studies].”
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Aristada, injection, suspension, extended release
Indications and Usage, quoted from the label by Alkermes, Inc. (NDA207533). Cross-references to other label sections are left out.
ARISTADA is indicated for the treatment of schizophrenia in adults [see Clinical Studies].
Source: DailyMed label, set id 17a8d11b-73b0-4833-a0b4-cf1ef85edefb, version 32, effective January 28, 2025. NDC 65757-401, one of 4 listings for this product.
Questions
What is Aristada used for?
The FDA label says: “ARISTADA is indicated for the treatment of schizophrenia in adults [see Clinical Studies].”
What drug class is Aristada?
FDA lists aripiprazole lauroxil 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 Aristada
- Is Aristada a controlled substance?Federal schedule
- Generic for AristadaFDA Orange Book
- Generic for Aristada Initio KitFDA Orange Book
- Atypical Antipsychotics listFDA drug class
- Aristada Medicare Part D coverageBy plan and state
- NDC 65757-401Aristada NDC record
- NDC 65757-402Aristada NDC record
- NDC 65757-403Aristada NDC record