Haloperidol
Haloperidol is a typical (older-generation) antipsychotic used to treat schizophrenia and other psychotic disorders, and, in some oral and injection products, Tourette’s Disorder and severe behavior problems in children.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 80 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Haloperidol is an older antipsychotic, available as a generic and around for decades, that treats schizophrenia and other psychotic disorders (plus Tourette’s Disorder for some products) by blocking dopamine. Newer antipsychotics are usually tried first, but it remains a familiar standby. It causes more movement side effects than most newer antipsychotics, such as stiffness, tremor, slowed movement and akathisia (an inner restlessness that makes sitting still hard). It carries a boxed warning for a higher risk of death in older adults with dementia-related psychosis, and it can cause serious heart rhythm problems. Report fever with severe stiffness, fainting, a racing heartbeat or new uncontrolled movements (possible tardive dyskinesia) promptly.
Clinical pearls
- Haloperidol decanoate, the long-acting injection, is meant for people already stable on oral haloperidol and is given every 4 weeks.
- Tell every prescriber you take it, since antibiotics like erythromycin or levofloxacin, plus methadone, can add to its heart rhythm risk.
- Your prescriber may check an ECG (heart tracing) and potassium and magnesium levels, especially if you take a water pill or steroid.
- If you also take lithium, report weakness, fever, tremor or confusion promptly, because the combination has caused a serious brain syndrome.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Older adults with dementia-related psychosis who take antipsychotics like haloperidol have a higher risk of death. In trials lasting about 10 weeks, about 4.5% of drug-treated patients died, compared with about 2.6% on placebo. Most deaths were heart-related (such as heart failure or sudden death) or infections (such as pneumonia). Haloperidol decanoate injection is not approved for dementia-related psychosis.
Patient information guide A plain-language walkthrough of Haloperidol, written from its FDA label.
What Haloperidol is used for
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Haloperidol is used for several conditions, depending on the product.
- Schizophrenia: Haloperidol injection products, including Haloperidol Lactate.
- Schizophrenia in adults previously stable on immediate-release oral haloperidol: Haldol Decanoate.
- Schizophrenia needing prolonged injectable therapy: Haloperidol Decanoate.
- Psychotic disorders: Haloperidol tablets and oral solution.
- Tics and vocal utterances of Tourette’s Disorder: Haloperidol tablets and oral solution (children and adults), and one Haloperidol injection product.
- Severe behavior problems and hyperactivity in children: Haloperidol tablets and oral solution, only after other treatments fail.
How Haloperidol works
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How haloperidol helps in schizophrenia is not fully understood. It may block dopamine type 2 receptors in the brain. It also binds more weakly to alpha-1 adrenergic receptors and barely binds to muscarinic or histamine (H1) receptors.
Haloperidol dosage
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Dosing is individualized and adjusted to your response.
- Tablets and oral solution are taken by mouth, usually a few times daily.
- Haldol Decanoate is injected deep into a muscle by a healthcare provider every 4 weeks. It is never given into a vein.
- Haloperidol injection products are given into a muscle.
Follow your prescriber and the product label.
Dosing details from the FDA-approved label
From the Haloperidol prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Schizophrenic patients requiring prolonged parenteral antipsychotic therapy: initial conversion from oral haloperidol
- Initial dose of haloperidol decanoate that is 10 to 20 times the previous daily dose in oral haloperidol equivalents, by deep intramuscular injection
- Maximum: The initial dose should not exceed 100 mg regardless of previous antipsychotic dose requirements; if conversion requires more than 100 mg, give a maximum of 100 mg initially followed by the balance in 3 to 7 days
- Maximum volume per injection site should not exceed 3 mL; do not administer intravenously
- Patients who are elderly, debilitated, or stable on low doses of oral haloperidol (e.g. up to the equivalent of 10 mg/day oral haloperidol)
- 10 to 15 times the previous daily dose in oral haloperidol equivalents for initial conversion (first month)
- Maximum: The initial dose should not exceed 100 mg
- Limited clinical experience suggests lower initial doses may be adequate
- Patients previously maintained on higher doses of antipsychotics (risk of relapse) or tolerant to oral haloperidol
- 20 times the previous daily dose in oral haloperidol equivalents should be considered for initial conversion, with downward titration on succeeding injections
- Maximum: The initial dose should not exceed 100 mg
- Maintenance therapy
- Individualized with titration upward or downward based on therapeutic response
- Usual maintenance range is 10 to 15 times the previous daily dose in oral haloperidol equivalents
- Usually administered monthly or every 4 weeks
- Maximum: Clinical experience at doses greater than 450 mg per month has been limited
- Variation in patient response may require adjustment of the dosing interval as well as the dose
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION There is considerable variation from patient to patient in the amount of medication required for treatment. As with all antipsychotic drugs, dosage should be individualized according to the needs and response of each patient. Dosage adjustments, either upward or downward, should be carried out as rapidly as practicable to achieve optimum therapeutic control. To determine the initial dosage, consideration should be given to the patient's age, severity of illness, previous response to other antipsychotic drugs, and any concomitant medication or disease state. Children, debilitated or geriatric patients, as well as those with a history of adverse reactions to antipsychotic drugs, may require less haloperidol. The optimal response in such patients is usually obtained with more gradual dosage adjustments and at lower dosage levels, as recommended below. Clinical experience suggests the following recommendations: Oral Administration Initial Dosage Range Adults Moderate Symptomatology - 0.5 mg to 2 mg b.i.d. or t.i.d. Severe Symptomatology - 3 mg to 5 mg b.i.d. or t.i.d. To achieve prompt control, higher doses may be required in some cases. Geriatric or Debilitated Patients - 0.5 mg to 2 mg b.i.d. or t.i.d. Chronic or Resistant Patients - 3 mg to 5 mg b.i.d. or t.i.d. Patients who remain severely disturbed or inadequately controlled may require dosage adjustment. Daily dosages up to 100 mg may be necessary in some cases to achieve an optimal response. Infrequently, haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses. Children The following recommendations apply to children between the ages of 3 and 12 years (weight range 15 kg to 40 kg). Haloperidol is not intended for children under 3 years old. Therapy should begin at the lowest dose possible (0.5 mg per day). If required, the dose should be increased by an increment of 0.5 mg at 5 to 7 day intervals until the desired therapeutic effect is obtained. (See chart below.) The total dose may be divided, to be given b.i.d. or t.i.d. Psychotic Disorders - 0.05 mg/kg/day to 0.15 mg/kg/day Nonpsychotic Behavior Disorders and Tourette's Disorder - 0.05 mg/kg/day to 0.075 mg/kg/day Severely disturbed psychotic children may require higher doses.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Haloperidol side effects
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Reported side effects include:
Common side effects
- Parkinsonism (stiffness, tremor, slowed movement)
- Oculogyric crisis (eyes locked in an upward gaze)
- Akinesia (reduced movement)
- Akathisia (inner restlessness)
- Tremor
- Headache
- Abdominal pain
When to get medical help
- Fever with severe muscle stiffness, confusion, or irregular pulse or blood pressure (possible neuroleptic malignant syndrome). Get emergency help.
- Fainting, a racing or irregular heartbeat, or dizziness (possible QT prolongation or torsades de pointes, a dangerous heart rhythm)
- Uncontrolled, repetitive muscle movements (possible tardive dyskinesia)
- Rash, swelling of the face or throat, or trouble breathing (allergic reaction)
- Signs of infection or a low white blood cell count
- Weakness, lethargy, fever, tremor, or confusion if you also take lithium
- Seizures
- Falls, severe sleepiness, or stroke symptoms
Haloperidol warnings and precautions
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- Older adults with dementia-related psychosis have a higher risk of death (boxed warning).
- Sudden death, QT prolongation, and torsades de pointes (a dangerous heart rhythm) have been reported.
- Tardive dyskinesia may be irreversible.
- Neuroleptic malignant syndrome is potentially fatal.
- Low blood pressure, falls, seizures, and low white blood cell counts can occur.
- It can impair thinking and driving.
Haloperidol interactions
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Several medicines can change haloperidol’s effects.
- QT-prolonging drugs (amiodarone, sotalol, citalopram, methadone, ziprasidone): higher risk of heart rhythm problems.
- CYP3A4 or CYP2D6 inhibitors (ketoconazole, paroxetine, fluoxetine, ritonavir): raise haloperidol levels.
- Carbamazepine, phenytoin, phenobarbital, rifampin, St John’s Wort: lower haloperidol levels.
- Lithium: rare serious brain toxicity.
- Alcohol, opioids, anesthetics: added sedation.
- Levodopa: haloperidol may weaken its effect.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Haloperidol
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- Not for Parkinson’s disease, dementia with Lewy bodies, severe CNS depression or coma, or known allergy to haloperidol.
- Tell your doctor about heart disease, long QT, electrolyte problems, thyroid problems, seizures, or low white blood cells.
- Pregnancy: newborns exposed in the third trimester may have movement problems or withdrawal symptoms.
- Breastfeeding: haloperidol passes into milk. Watch the baby for sleepiness and feeding problems.
- Older adults and people with liver problems may need lower starting doses.
- Haloperidol decanoate injection is not established for children.
Haloperidol overdose
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Overdose can cause severe muscle rigidity or tremor, very low blood pressure, heavy sedation, and even coma with slowed breathing. Heart rhythm changes are also possible. There is no specific antidote, and care is supportive. Call Poison Control at 1-800-222-1222.
What Haloperidol does in the body
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How haloperidol’s blood levels relate to its safety and effectiveness has not been fully characterized.
How your body processes Haloperidol
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After a haloperidol decanoate injection, blood levels peak at about 6 days. The half-life is about 3 weeks, and steady state takes 2 to 4 months of monthly injections. The liver breaks haloperidol down, mainly through glucuronidation and CYP3A4. Less than 3% leaves unchanged in urine. Levels may be higher in older adults and in people with liver problems.
How to store Haloperidol
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Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) Protect from light.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Haloperidol
211 supplements and herbal products have documented interactions with Haloperidol in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 11
- Moderate · 157
- Minor · 43
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Haloperidol: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Haloperidol — the kind of thing our pharmacy team would talk through with you at the counter.
What is haloperidol for?
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How do I take it?
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What side effects should I expect?
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When should I call my doctor right away?
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Can I drink alcohol or take other medicines with it?
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Is it safe in pregnancy or for older adults?
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Is Haloperidol available over the counter?
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When was Haloperidol first available?
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Who makes Haloperidol?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Haloperidol on HelloPharmacist
Haloperidol forms and strengths (how it comes)
Haloperidol is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Haloperidol tablets are used for psychotic disorders.
- Haloperidol tablets are used for tics and vocal utterances of Tourette’s Disorder in children and adults.
- Haloperidol tablets are used for severe behavior problems or hyperactivity in children after other treatments have failed.
- Haloperidol tablets dosing is individualized and adjusted to response.
- Haloperidol tablets may need lower doses in children, older adults, and debilitated patients.
Injection
How this form is used
- Haldol Decanoate is for schizophrenia in adults previously stable on immediate-release oral haloperidol.
- Haloperidol Decanoate is for schizophrenia in patients who need prolonged injectable antipsychotic therapy.
- Haloperidol Lactate and Haloperidol injection are used for schizophrenia.
- One Haloperidol injection product is also labeled for Tourette’s Disorder.
- Haldol Decanoate is given by a healthcare provider as a deep intramuscular injection every 4 weeks.
- Haldol Decanoate and Haloperidol Decanoate must not be given into a vein.
- Haloperidol Decanoate is for patients already stabilized on antipsychotic medication.
Oral solution
How this form is used
- Haloperidol oral solution is used for psychotic disorders.
- Haloperidol oral solution is used for tics and vocal utterances of Tourette’s Disorder in children and adults.
- Haloperidol oral solution is used for severe behavior problems or hyperactivity in children after other treatments have failed.
- Haloperidol oral solution dosing is individualized and adjusted to response.
- Haloperidol oral solution may need lower doses in children, older adults, and debilitated patients.
Haloperidol on the U.S. market: products, makers and brands
How Haloperidol appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
42 companies list 231 Haloperidol product records with the FDA, mostly as tablet, injection, oral solution; the earliest marketing or approval year on record is 1986. Brand names on the directory include Haldol, Haloperidol Decanoate, Haloperidol Lactate; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (15) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Haloperidol is used (Medicaid data)
A general measure of how commonly Haloperidol is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Haloperidol is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Haloperidol prescribed? Of the 1,601 medications we measure, Haloperidol ranks #197 by Medicaid prescriptions — more than 88% of them.
Utilization by Haloperidol product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
haloperidol 5 MG Oral Tablet Most dispensed
Summed across the 13 of 73 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310672
1 ML haloperidol decanoate 100 MG/ML Injection
Summed across the 21 of 45 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1719803
haloperidol 10 MG Oral Tablet
Summed across the 9 of 49 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 314035
haloperidol 2 MG Oral Tablet
Summed across the 9 of 53 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 314034
1 ML haloperidol 5 MG/ML Injection
Summed across the 3 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1719646
haloperidol 1 MG Oral Tablet
Summed across the 9 of 55 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310671
1 ML haloperidol decanoate 50 MG/ML Injection
Summed across the 16 of 40 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1719862
haloperidol 20 MG Oral Tablet
Summed across the 6 of 41 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197754
haloperidol 0.5 MG Oral Tablet
Summed across the 9 of 48 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310670
haloperidol 2 MG/ML Oral Solution
Summed across the 7 of 13 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 141935
haloperidol decanoate 100 MG/ML Injectable Solution
Summed across the 5 of 31 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 859871
haloperidol 5 MG/ML Injectable Solution
Summed across the 2 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 204416
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Haloperidol, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 109 of 470 listed Haloperidol NDCs with Medicaid activity.
Compare Haloperidol products
A representative set of FDA-listed product records for Haloperidol — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 50 mg/mL | Intramuscular | Armas Pharmaceuticals Inc. | ANDA | View NDC → |
| 100 mg/mL | Intramuscular | Armas Pharmaceuticals Inc. | ANDA | View NDC → |
| 500 mg/5 mL | Intramuscular | Armas Pharmaceuticals Inc. | ANDA | View NDC → |
| 50 mg/mL | Intramuscular | BluePoint Laboratories × 3 listings | ANDA | View NDC → |
| 100 mg/mL | Intramuscular | BluePoint Laboratories × 3 listings | ANDA | View NDC → |
| 500 mg/5 mL | Intramuscular | BluePoint Laboratories × 2 listings | ANDA | View NDC → |
| 50 mg/mL | Intramuscular | Caplin Steriles Limited | ANDA | View NDC → |
| 100 mg/mL | Intramuscular | Caplin Steriles Limited × 2 listings | ANDA | View NDC → |
| 5 mg/mL | Intramuscular | Cardinal Health 107, LLC × 2 listings | ANDA | View NDC → |
| 5 mg/mL | Intramuscular | Fresenius Kabi USA, LLC | ANDA | View NDC → |
| 50 mg/mL | Intramuscular | Fresenius Kabi USA, LLC | ANDA | View NDC → |
| 100 mg/mL | Intramuscular | Fresenius Kabi USA, LLC | ANDA | View NDC → |
| 50 mg/mL | Intramuscular | Gland Pharma Limited | ANDA | View NDC → |
| 100 mg/mL | Intramuscular | Gland Pharma Limited | ANDA | View NDC → |
| 5 mg/mL | Intramuscular | Henry Schein, Inc. | ANDA | View NDC → |
| 5 mg/mL | Intramuscular | HF Acquisition Co LLC, DBA HealthFirst | ANDA | View NDC → |
| 5 mg/mL | Intramuscular | Hikma Pharmaceuticals USA Inc. × 3 listings | ANDA | View NDC → |
| 100 mg/mL | Intramuscular | Hikma Pharmaceuticals USA Inc. × 2 listings | ANDA | View NDC → |
| 50 mg/mL | Intramuscular | Lifestar Pharma LLC | ANDA | View NDC → |
| 100 mg/mL | Intramuscular | Lifestar Pharma LLC | ANDA | View NDC → |
| 250 mg/5 mL | Intramuscular | Lifestar Pharma LLC | ANDA | View NDC → |
| 500 mg/5 mL | Intramuscular | Lifestar Pharma LLC | ANDA | View NDC → |
| 50 mg/mL | Intramuscular | Meitheal Pharmaceuticals Inc. | ANDA | View NDC → |
| 100 mg/mL | Intramuscular | Meitheal Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 5 mg/mL | Intramuscular | Mylan Institutional LLC | ANDA | View NDC → |
| 50 mg/mL | Intramuscular | Mylan Institutional LLC | ANDA | View NDC → |
| 100 mg/mL | Intramuscular | Mylan Institutional LLC | ANDA | View NDC → |
| 100 mg/mL | Intramuscular | NorthStar RxLLC | ANDA | View NDC → |
| 50 mg/mL | Intramuscular | Patriot Pharmaceuticals LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 100 mg/mL | Intramuscular | Patriot Pharmaceuticals LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 5 mg/mL | Intramuscular | Remedyrepack Inc. × 2 listings | ANDA | View NDC → |
| 50 mg/mL | Intramuscular | Remedyrepack Inc. × 2 listings | ANDA | View NDC → |
| 100 mg/mL | Intramuscular | Remedyrepack Inc. × 2 listings | ANDA | View NDC → |
| 50 mg/mL | Intramuscular | Sagent Pharmaceuticals | ANDA | View NDC → |
| 100 mg/mL | Intramuscular | Sagent Pharmaceuticals | ANDA | View NDC → |
| 500 mg/5 mL | Intramuscular | Sagent Pharmaceuticals | ANDA | View NDC → |
| 50 mg/mL | Intramuscular | Somerset Therapeutics, LLC × 4 listings | ANDA | View NDC → |
| 100 mg/mL | Intramuscular | Somerset Therapeutics, LLC × 5 listings | ANDA | View NDC → |
| 50 mg/mL | Intramuscular | Zydus Lifesciences Limited × 2 listings | ANDA | View NDC → |
| 100 mg/mL | Intramuscular | Zydus Lifesciences Limited × 2 listings | ANDA | View NDC → |
| 50 mg/mL | Intramuscular | Zydus Pharmaceuticals USA Inc. × 2 listings | ANDA | View NDC → |
| 100 mg/mL | Intramuscular | Zydus Pharmaceuticals USA Inc. × 2 listings | ANDA | View NDC → |
| 💊Oral solution | ||||
| 2 mg/mL | Oral | Advagen Pharma Ltd | ANDA | View NDC → |
| 2 mg/mL | Oral | American Health Packaging | ANDA | View NDC → |
| 2 mg/mL | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| 2 mg/mL | Oral | PAI Holdings, LLC dba PAI Pharma | ANDA | View NDC → |
| 💊Tablet | ||||
| 0.5 mg | Oral | AiPing Pharmaceutical, Inc | ANDA | View NDC → |
| 1 mg | Oral | AiPing Pharmaceutical, Inc | ANDA | View NDC → |
| 2 mg | Oral | AiPing Pharmaceutical, Inc | ANDA | View NDC → |
| 5 mg | Oral | AiPing Pharmaceutical, Inc | ANDA | View NDC → |
| 10 mg | Oral | AiPing Pharmaceutical, Inc | ANDA | View NDC → |
| 20 mg | Oral | AiPing Pharmaceutical, Inc | ANDA | View NDC → |
| 0.5 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 1 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 2 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 5 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 10 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 20 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 5 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 10 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 20 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 0.5 mg | Oral | Amici Pharmaceuticals, LLC | ANDA | View NDC → |
| 1 mg | Oral | Amici Pharmaceuticals, LLC | ANDA | View NDC → |
| 2 mg | Oral | Amici Pharmaceuticals, LLC | ANDA | View NDC → |
| 5 mg | Oral | Amici Pharmaceuticals, LLC | ANDA | View NDC → |
| 10 mg | Oral | Amici Pharmaceuticals, LLC | ANDA | View NDC → |
| 20 mg | Oral | Amici Pharmaceuticals, LLC | ANDA | View NDC → |
| 0.5 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 1 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 2 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 5 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 10 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 20 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 0.5 mg | Oral | Bryant Ranch Prepack × 5 listings | ANDA | View NDC → |
| 1 mg | Oral | Bryant Ranch Prepack × 4 listings | ANDA | View NDC → |
| 2 mg | Oral | Bryant Ranch Prepack × 6 listings | ANDA | View NDC → |
| 5 mg | Oral | Bryant Ranch Prepack × 5 listings | ANDA | View NDC → |
| 10 mg | Oral | Bryant Ranch Prepack × 3 listings | ANDA | View NDC → |
| 20 mg | Oral | Bryant Ranch Prepack × 3 listings | ANDA | View NDC → |
Showing 124 of 231 products — FDA National Drug Code Directory. See every product, package size and price: browse all 231 Haloperidol NDCs →
Haloperidol side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Haloperidol — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Haloperidol in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Haloperidol FDA approval history
How Haloperidol went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Haloperidol recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list 4 Haloperidol recalls since July 2021, covering 9 product listings. All of them are still ongoing or began in the last six months. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26605. NDC: 67457-426-12 w… Lots: Lot 25381993 and 25391516, Exp 12/31/2026 FDA record D-0214-2026 →
- Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, In… Lots: A240482B, EXP 08/31/2026 FDA record D-0369-2025 →
- Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka,… Lots: A240482A, EXP 08/31/2026 FDA record D-0368-2025 →
- Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India,… Lots: A240467B, EXP 07/31/2026 FDA record D-0367-2025 →
- Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10 Lots: A240482D, exp. date 08/2026 FDA record D-0358-2025 →
- Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (in… Lots: NDC 68001-581-41; A240482A, exp. date 08/2026; NDC 68001-581-48; A240482B, exp. date 08/2026 FDA record D-0357-2025 →
- Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41 Lots: A240467B, exp. date 07/2026 FDA record D-0356-2025 →
- Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10… Lots: NDC 70069-381-01; A240467A, exp. date 07/2026; NDC 70069-381-10; A240467C, exp. date 07/2026 FDA record D-0355-2025 →
- Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics,… Lots: Lot #: a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025 FDA record D-0506-2024 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 5093 6 dose forms · 21 strengths
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Dose form (SCDF) Injectable Solution RxCUI 372375In current FDA listingsClinical drug / strength (SCD) decanoate 100 MG/MLRxCUI 859871decanoate 50 MG/MLRxCUI 8598675 MG/MLRxCUI 20441610 MG/MLRxCUI 199953 -
Dose form (SCDF) Injection RxCUI 1719645In current FDA listingsClinical drug / strength (SCD) 1 ML haloperidol 5 MG/MLRxCUI 17196461 ML haloperidol decanoate 100 MG/MLRxCUI 17198031 ML haloperidol decanoate 50 MG/MLRxCUI 1719862 -
Dose form (SCDF) Oral Capsule RxCUI 376237No current FDA listingClinical drug / strength (SCD) 0.5 MGRxCUI 249960 -
Dose form (SCDF) Oral Solution RxCUI 372376In current FDA listingsClinical drug / strength (SCD) 0.2 MG/MLRxCUI 1088730.3 MG/MLRxCUI 1083750.4 MG/MLRxCUI 1088721 MG/MLRxCUI 3106732 MG/MLRxCUI 141935 -
Dose form (SCDF) Oral Tablet RxCUI 372377In current FDA listings -
Dose form (SCDF) Prefilled Syringe RxCUI 1876501No current FDA listingClinical drug / strength (SCD) 1 ML haloperidol 5 MG/MLRxCUI 1876502
Look up RxCUI 5093 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Haloperidol supply and shortage status
Whether Haloperidol is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Haloperidol brand names
Haloperidol is sold under 3 brand names in the FDA directory — Haldol, Haloperidol Decanoate, Haloperidol Lactate. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Haloperidol: manufacturers and labelers
42 companies list Haloperidol products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Remedyrepack Inc., Method Pharmaceuticals, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 18 more on the FDA NDC directory.
Haloperidol drug class (RxNorm)
Haloperidol belongs to the Typical Antipsychotic class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Haloperidol page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Lifestar Pharma LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →