NDC 58657-0704-01

Haloperidol 10 mg/1 TABLET

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NDC

58657-0704-01

Generic Name

Haloperidol

Brand Name

Haloperidol

Strength

10 mg/1

Dosage Form

TABLET

Route

ORAL

Package Size

—

Labeler

Method Pharmaceuticals, LLC

FDA Drug Information

Indications & Usage

INDICATIONS AND USAGE Haloperidol tablets, USP are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets, USP are indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol tablets, USP are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets, USP are also effective…

Important Warnings

WARNINGS 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. Haloperidol is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING ). Cardiovascular Effects Cases of sudden death, QT-prolongation, and Torsades de pointes hav…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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Other Haloperidol NDC Codes

69292-0590-0120 mg/1TABLET

2-Day

69292-0586-015 mg/1TABLET

2-Day

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