Prescription medicine

Molindone First approved as Moban

Molindone (Moban) is a prescription medicine with an FDA approval on record since 1974. FDA's NDC Directory lists it from 1 generic labeler.

Generic listed
Boxed warning

Check it at the source: the molindone FDA label on DailyMed (effective December 17, 2025, EPIC PHARMA, LLC); the NDA 17111 record on Drugs@FDA; every molindone label on DailyMed.

Highlights of the record

FDA label of December 17, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Boxed warning

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 ).

Used for

From the label: indications and usage
Molindone Hydrochloride Tablets, USP are indicated for the management of schizophrenia.

Forms and strengths

5 mg
10 mg
25 mg

Tablet.

On the market

Earliest approval on file: January 18, 1974 Moban, Chartwell Rx; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 1 first March 20, 2015; 1 with a marketed status in Drugs@FDA
Labelers listed (NDC): 1 of which 1 under generic applications, 0 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 2 through July 30, 2026

What is molindone used for?

From the label: indications 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.

Conditions named in the indications of molindone's FDA labels, with every medicine labeled for each:

Schizophrenia

From other molindone labels
Schizophrenia: INDICATIONS AND USAGE Molindone Hydrochloride Tablets, USP are indicated for the management of schizophrenia.

FDA pharmacologic class: Typical Antipsychotic.

Source: FDA drug label (Molindone Hydrochloride), EPIC PHARMA, LLC, effective December 17, 2025 (SPL set 1275e92f-9573-4d0c-8e77-1c9ac47696d2), via openFDA; the full label on DailyMed

Is there a generic for molindone (Moban)?

The FDA approved the first generic molindone on March 20, 2015. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists molindone from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

1974 earliest approval on file
2015 first generic approved

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do FAERS reports show for molindone?

The FDA Adverse Event Reporting System holds 2 reports that list molindone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 0 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

Hypersensitivity1
Nephropathy Toxic1

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as molindone?

16 other medicines are given the same way (oral) and in the same FDA class as molindone or labeled mainly for the same use (schizophrenia), the same class first. Schizophrenia lists all 24 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (oral)	Pharmacy cost	Shortage
Haloperidol	Schizophrenia	28 labelers	$0.181 per tablet 5 mg tablet	A presentation being discontinued
Thiothixene	Schizophrenia	4 labelers	$1.72 per capsule 10 mg capsule	No current entry
Quetiapine	Schizophrenia	50 labelers	$0.127 per tablet 300 mg tablet	No current entry
Olanzapine	Schizophrenia	33 labelers	$0.147 per tablet 20 mg tablet	No current entry
Lurasidone	Schizophrenia	29 labelers	$0.142 per tablet 20 mg tablet	No current entry
Chlorpromazine	Schizophrenia	22 labelers	$0.552 per tablet 100 mg tablet	No current entry
Perphenazine	Schizophrenia	16 labelers	$0.161 per tablet 4 mg tablet	No current entry
Paliperidone	Schizophrenia	18 labelers	$0.972 per tablet 3 mg tablet	No current entry

Every medicine labeled for the same conditions as molindone

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to molindone: 16 medicines for the same use
Other typical antipsychotics: the pharmacologic class, with prices and generics
Molindone side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other