FDA label
What is aripiprazole used for?
The FDA-approved uses of aripiprazole, 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: “Aripiprazole Tablets are indicated for the treatment of: Schizophrenia; Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder; Irritability Associated with Autistic Disorder; Treatment of Tourette’s Disorder.”
Run it in Rivvi
Which 2027 plans near you dropped or restricted aripiprazole?
Tier changes and new prior auth, step therapy or quantity limits, plan by plan.
Free to start. Opens Rivvi, the AI workspace for healthcare teams.
Aripiprazole, tablet
Indications and Usage, quoted from the label by Solco Healthcare U.S., LLC (ANDA205363). Cross-references to other label sections are left out.
Aripiprazole Tablets are indicated for the treatment of:
- Schizophrenia
- Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder
- Irritability Associated with Autistic Disorder
- Treatment of Tourette’s Disorder
Source: DailyMed label, set id 686d0088-ac61-41df-8909-ae12f7957644, version 8, effective August 30, 2026. NDC 43547-302, one of 233 listings for this product.
Aripiprazole Oral, solution
Indications and Usage, quoted from the label by ATLANTIC BIOLOGICALS CORP. (ANDA216150). Cross-references to other label sections are left out.
Aripiprazole oral solution is indicated for the treatment of: • Schizophrenia [see Clinical Studies] • Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [see Clinical Studies] • Irritability Associated with Autistic Disorder [see Clinical Studies] • Treatment of Tourette’s Disorder [see Clinical Studies]
Source: DailyMed label, set id 042b725c-1c17-4cfb-80b2-c841226d795e, version 2, effective July 10, 2026. NDC 17856-0684, one of 11 listings for this product.
Questions
What is aripiprazole used for?
The FDA label says: “Aripiprazole Tablets are indicated for the treatment of: Schizophrenia; Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder; Irritability Associated with Autistic Disorder; Treatment of Tourette’s Disorder.”
What drug class is aripiprazole?
FDA lists aripiprazole 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 Aripiprazole
- Is Aripiprazole a controlled substance?Federal schedule
- Generic for OpipzaFDA Orange Book
- Generic for Abilify Maintena KitFDA Orange Book
- Generic for AbilifyFDA Orange Book
- Generic for Abilify AsimtufiiFDA Orange Book
- Generic for Abilify Mycite KitFDA Orange Book
- What is Abilify Asimtufii used for?FDA label uses
- Is Abilify Asimtufii a controlled substance?Federal schedule
- Atypical Antipsychotics listFDA drug class
- Aripiprazole Medicare Part D coverageBy plan and state
- NDC 15370-401Aripiprazole NDC record
- NDC 15370-402Aripiprazole NDC record
- NDC 15370-403Aripiprazole NDC record