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Molindone Hydrochloride
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Molindone Hydrochloride | 10 mg/1 | 1298816 | — |
| Molindone Hydrochloride | 25 mg/1 | 1298816 | — |
| Molindone Hydrochloride | 5 mg/1 | 1298816 | — |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Typical Antipsychotic [EPC] | EPC | All 10 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 090453-001 | MOLINDONE HYDROCHLORIDE | TABLET | MOLINDONE HYDROCHLORIDE | Prescription | — | ||
| 090453-002 | MOLINDONE HYDROCHLORIDE | TABLET | MOLINDONE HYDROCHLORIDE | Prescription | — | ||
| 090453-003 | MOLINDONE HYDROCHLORIDE | TABLET | MOLINDONE HYDROCHLORIDE | Prescription | — | RS |
Therapeutic equivalence
Source: Orange BookCodes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 11 | Labeling | Approved | January 22, 2025 | Standard |
| Supplement | 4 | Labeling | Approved | February 23, 2017 | Standard |
| Original application | 1 | Approved | March 20, 2015 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251217). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug LabelingWARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis – Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Molindone Hydrochloride Tablets, USP are not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).
Indications and Usage
openFDA Drug LabelingINDICATIONS AND USAGE Molindone Hydrochloride Tablets, USP are indicated for the management of schizophrenia. The efficacy of Molindone Hydrochloride Tablets, USP in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized, acutely ill, schizophrenic patients as subjects.
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION Initial and maintenance doses of Molindone Hydrochloride Tablets should be individualized. Initial Dosage Schedule The usual starting dosage is 50 to 75 mg/day. —Increase to 100 mg/day in 3 or 4 days. —Based on severity of symptomatology, dosage may be titrated up or down depending on individual patient response. —An increase to 225 mg/day may be required in patients with severe symptomatology. Elderly and debilitated patients should be started on lower dosage. Maintenance Dosage Schedule 1. Mild-5 mg to 15 mg three or four times a day. 2. Moderate-10 mg to 25 mg three or four times a day. Severe-225 mg/day may be required.
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Molindone Hydrochloride Tablets are contraindicated in severe central nervous system depression (alcohol, barbiturates, narcotics, etc.) or comatose states, and in patients with known hypersensitivity to the drug.
Warnings
openFDA Drug LabelingWARNINGS Increased Mortality in Elderly Patients with Dementia-Related Psychosis — Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Molindone Hydrochloride Tablets are not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING ). Tardive Dyskinesia Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown. Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying disease process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown. Given these considerations, antipsychotics should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that, 1) is known to respond to antipsychotic drugs, and 2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically. If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics, drug discontinuation should be considered. However, some patients may require treatment despite the presence of the syndrome. (For further information about the description of tardive dyskinesia and its clinical detection, please refer to the section on ADVERSE REACTIONS .) Falls Molindone Hydrochloride may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy. Neuroleptic Malignant Syndrome (NMS) A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central ne …
Adverse Reactions
openFDA Drug LabelingADVERSE REACTIONS CNS Effects The most frequently occurring effect is initial drowsiness that generally subsides with continued usage of the drug or lowering of the dose. Noted less frequently were depression, hyperactivity and euphoria. Neurological Extrapyramidal Symptoms Extrapyramidal symptoms noted below may occur in susceptible individuals and are usually reversible with appropriate management. Akathisia Motor restlessness may occur early. Parkinson Syndrome Akinesia, characterized by rigidity, immobility and reduction of voluntary movements and tremor, have been observed. Occurrence is less frequent than akathisia. Dystonia Class effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups. Tardive Dyskinesia Antipsychotic drugs are known to cause a syndrome of dyskinetic movements commonly referred to as tardive dyskinesia. The movements may appear during treatment or upon withdrawal of treatment and may be either reversible or irreversible (i.e., persistent) upon cessation of further antipsychotic administration. The syndrome is known to have a variable latency for development and the duration of the latency cannot be determined reliably. It is thus wise to assume that any antipsychotic agent has the capacity to induce the syndrome and act accordingly until sufficient data has been collected to settle the issue definitively for a specific drug product. In the case of antipsychotics known to produce the irreversible syndrome, the following has been observed. Tardive dyskinesia has appeared in some patients on long-term therapy and has also appeared after drug therapy has been discontinued. The risk appears to be greater in elderly patients on high-dose therapy, especially females. The symptoms are persistent and in some patients appear to be irreversible. The syndrome is characterized by rhythmical involuntary movements of the tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). There may be involuntary movements of extremities. There is no known effective treatment of tardive dyskinesia; antiparkinsonism agents usually do not alleviate the symptoms of this syndrome. It is suggested that all antipsychotic agents be discontinued if these symptoms appear. Should it be necessary to reinstitute treatment, or increase the dosage of the agent, or switch to a different antipsychotic agent, the syndrome may be masked. It has been reported that fine vermicular movements of the tongue may be an early sign of the syndrome and if the medication is stopped at that time the syndrome may not develop (See WARNINGS ). Autonomic Nervous System Occasionally blurring of vision, tachycardia, nausea, dry mouth and salivation have been reported. Urinary retention and constipation may occur particularly if anticholinergic drugs are used to treat extrapyramidal symptoms. One patient being treated with Molindone Hydrochloride experienced priapism which required surgical intervention, apparently resulting in residual impairment of erectile function. Laboratory Tests There have been rare reports of leucopenia and leucocytosis. If such reactions occur, treatment with Molindone Hydrochloride may continue if clinical symptoms are absent. Alterations of blood glucose, B.U.N., and red blood cells have not been considered clinically significant. Metabolic and Endocrine Effects Alteration of thyroid function has not been significant. Amenorrhea has been reported infreq …
Drug Interactions
openFDA Drug LabelingDrug Interactions Potentiation of drugs administered concurrently with Molindone Hydrochloride has not been reported. Additionally, animal studies have not shown increased toxicity when Molindone Hydrochloride is given concurrently with representative members of three classes of drugs (i.e., barbiturates, chloral hydrate and antiparkinson drugs).
Description
openFDA Drug LabelingDESCRIPTION Molindone Hydrochloride is a dihydroindolone compound which is not structurally related to the phenothiazines, the butyrophenones or the thioxanthenes. Molindone Hydrochloride is 3-ethyl-6, 7-dihydro-2-methyl-5-(morpholinomethyl) indol-4(5H)-one hydrochloride. It is a white to off-white or pale-pink crystalline powder, freely soluble in water and alcohol. Molindone Hydrochloride Tablets, USP contain the following inactive ingredients: alginic acid, calcium sulfate, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. Colors: 5 mg contains FD&C Yellow #6 Aluminum Lake 10 mg contains FD&C Blue #2 Aluminum Lake 25 mg contains FD&C Blue #2 Aluminum Lake, FD&C Yellow #6, Aluminum Lake and D&C Yellow #10 Aluminum Lake Molindone Hydrochloride is represented by the following structural formula: The empirical formula is C 16 H 24 N 2 O 2 •HCl representing a molecular weight of 312.83. structure formula.jpg
Overdosage
openFDA Drug LabelingOVERDOSAGE Symptomatic, supportive therapy should be the rule. Gastric lavage is indicated for the reduction of absorption of Molindone Hydrochloride which is freely soluble in water. Since the adsorption of Molindone Hydrochloride by activated charcoal has not been determined, the use of this antidote must be considered of theoretical value. Emesis in a comatose patient is contraindicated. Additionally, while the emetic effect of apomorphine is blocked by Molindone Hydrochloride in animals, this blocking effect has not been determined in humans. A significant increase in the rate of removal of unmetabolized Molindone Hydrochloride from the body by forced diuresis, peritoneal or renal dialysis would not be expected. (Only 2% of a single ingested dose of Molindone Hydrochloride is excreted unmetabolized in the urine). However, poor response of the patient may justify use of these procedures. While the use of laxatives or enemas might be based on general principles, the amount of unmetabolized Molindone Hydrochloride in feces is less than 1%. Extrapyramidal symptoms have responded to the use of Diphenhydramine (Benadryl ® ) * , Amantadine HCl (Symmetrel ® ) † and the synthetic anticholinergic antiparkinson agents, (i.e., Artane ®‡ , Cogentin ®§ , Akineton ®¶ ).
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Molindone Hydrochloride Tablets USP, 5 mg are light orange to orange, oval-shaped tablets, debossed " Є336 " on one side and plain on the other side. They are supplied as follows: Bottles of 100 NDC 42806-336-01 Molindone Hydrochloride Tablets USP, 10 mg are light blue to blue, oval-shaped tablets, debossed " Є337 " on one side and plain on the other side. They are supplied as follows: Bottles of 100 NDC 42806-337-01 Molindone Hydrochloride Tablets USP, 25 mg are light green to green, oval-shaped tablet, debossed " Є338 " on one side and bisect on the other side. They are supplied as follows: Bottles of 100 NDC 42806-338-01 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP TIGHTLY CLOSED * Benadryl is a registered trademark of Warner-Lambert. † Symmetrel is a registered trademark of Endo Pharmaceuticals Inc. ‡ Artane is a registered trademark of Lederle Laboratories. § Cogentin is a registered trademark of Merck & Co., Inc. ¶ Akineton is a registered trademark of Knoll Laboratories. Distributed by: Epic Pharma, LLC Laurelton NY, 11413 Rev. 11-2024-00 MF336REV11/24 OE2798
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: MOLINDONE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 42806-336-01 | 42806-336 | EPIC PHARMA, LLC | 100 TABLET in 1 BOTTLE (42806-336-01) | October 17, 2018 |
| 42806-337-01 | 42806-337 | EPIC PHARMA, LLC | 100 TABLET in 1 BOTTLE (42806-337-01) | October 17, 2018 |
| 42806-338-01 | 42806-338 | EPIC PHARMA, LLC | 100 TABLET in 1 BOTTLE (42806-338-01) | October 17, 2018 |
| 42806-336 | 42806-336 | EPIC PHARMA, LLC | — | October 17, 2018 |
| 42806-337 | 42806-337 | EPIC PHARMA, LLC | — | October 17, 2018 |
| 42806-338 | 42806-338 | EPIC PHARMA, LLC | — | October 17, 2018 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 11 sections on this page.