FDA label
What is haloperidol decanoate used for?
The FDA-approved uses of haloperidol decanoate, 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: “Haloperidol decanoate injection is indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate-release oral haloperidol product.”
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Haloperidol Decanoate, injection
Indications and Usage, quoted from the label by Somerset Therapeutics, LLC (ANDA209101). Cross-references to other label sections are left out.
Haloperidol decanoate injection is indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate-release oral haloperidol product.
Source: DailyMed label, set id f2bff27f-929f-4f7d-b3eb-084ebc2a885f, version 23, effective October 12, 2026. NDC 70069-030, one of 52 listings for this product.
Haloperidol Decanoate, injection, solution
Indications and Usage, quoted from the label by Sagent Pharmaceuticals (ANDA205241). Cross-references to other label sections are left out.
Haloperidol decanoate injection, 50 mg/mL and haloperidol decanoate injection, 100 mg/mL are indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy.
Source: DailyMed label, set id b3167043-585f-482f-b8a7-591bc2721bd3, version 5, effective February 27, 2024. NDC 25021-831, one of 3 listings for this product.
Questions
What is haloperidol decanoate used for?
The FDA label says: “Haloperidol decanoate injection is indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate-release oral haloperidol product.”
What drug class is haloperidol decanoate?
FDA lists haloperidol decanoate in the Typical 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.