FDA label
What is Nuedexta used for?
Nuedexta contains dextromethorphan and quinidine. The FDA-approved uses below are 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: “NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA).”
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Nuedexta, capsule, gelatin coated
Indications and Usage, quoted from the label by Otsuka America Pharmaceutical, Inc (NDA021879). Cross-references to other label sections are left out.
NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA).
PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state. PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurological disease or injury.
Source: DailyMed label, set id c8cce784-8c5f-415b-8068-76e5d481d159, version 4, effective January 22, 2026. NDC 59148-053, one of 2 listings for this product.
Questions
What is Nuedexta used for?
The FDA label says: “NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA).”
What drug class is Nuedexta?
FDA lists dextromethorphan and quinidine in the Antiarrhythmic and Cytochrome P450 2D6 Inhibitor and Sigma-1 Agonist and Uncompetitive N-methyl-D-aspartate Receptor Antagonist 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.
More on Nuedexta
- Is Nuedexta a controlled substance?Federal schedule
- Generic for NuedextaFDA Orange Book
- Antiarrhythmics listFDA drug class
- Cytochrome P450 2D6 Inhibitors listFDA drug class
- Sigma-1 Agonists listFDA drug class
- Uncompetitive N-methyl-D-aspartate Receptor Antagonists listFDA drug class
- NDC 59148-053Nuedexta NDC record
- NDC 64597-301Nuedexta NDC record