Quick answers
- What is Cariprazine used for?
- The FDA-approved label (Vraylar, Allergan, Inc., December 18, 2025) says: “. INDICATIONS AND USAGE VRAYLAR ® is indicated for: • Treatment of schizophrenia in adult and pediatric patients 13 years of age and older […] • Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older […] • Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients […] • Adjunctive therapy …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cariprazine have a boxed warning?
- Yes. The FDA label for Vraylar has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Cariprazine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cariprazine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Cariprazine?
- 1 company lists prescription products of Cariprazine in the FDA NDC Directory, including Allergan, Inc..
What Cariprazine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
. INDICATIONS AND USAGE VRAYLAR ® is indicated for: • Treatment of schizophrenia in adult and pediatric patients 13 years of age and older […] • Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older […] • Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients […] • Adjunctive therapy …
— FDA label: Vraylar, Allergan, Inc., effective December 18, 2025. Read the full label on DailyMed →
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. Read it on the full label →
Forms and how it is given
| Dosage forms | Capsule, gelatin coated |
|---|---|
| Route | Oral |
| Prescription products | 6 in the FDA NDC Directory |
| Brand names | Vraylar |
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 |
|---|---|---|
| cariprazine 0.5 mg capsule, gelatin coated | Brand: Vraylar | $50.77 per capsule |
| cariprazine 0.75 mg capsule, gelatin coated | Brand: Vraylar | $50.81 per capsule |
| cariprazine 1.5 mg capsule, gelatin coated | Brand: Vraylar | $50.83 per capsule |
| cariprazine 3 mg capsule, gelatin coated | Brand: Vraylar | $50.86 per capsule |
| cariprazine 4.5 mg capsule, gelatin coated | Brand: Vraylar | $50.78 per capsule |
| cariprazine 6 mg capsule, gelatin coated | Brand: Vraylar | $50.76 per capsule |
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.
- Allergan, Inc.6 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA204370 VRAYLAR | Abbvie | September 17, 2015 | 11, latest December 18, 2025 2025: Efficacy · 2025: Efficacy · 2025: Efficacy |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Vraylar, Allergan, Inc., effective December 18, 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 →