Prescription medicine
Dextromethorphan and quinidine Brand names: Nuedexta
Dextromethorphan and quinidine (Nuedexta) is a prescription medicine with an FDA approval on record since 2010. A generic is approved and listed by 4 labelers, but in the October 7, 2026 NADAC survey pharmacies bought only the brand, at $26.64 per Nuedexta 20-10 mg capsule.
- Generic approved
Check it at the source: the dextromethorphan and quinidine FDA label on DailyMed (effective July 8, 2026, Sun Pharmaceutical Industries, Inc.); the NDA 21879 record on Drugs@FDA; every dextromethorphan and quinidine label on DailyMed.
Highlights of the record
FDA label of July 8, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageDextromethorphan hydrobromide and quinidine sulfate capsules are indicated for the treatment of pseudobulbar affect (PBA).
Forms and strengths
- 20 mg / 10 mg
Capsule; gelatin-coated capsule.
On the market
- Earliest approval on file
- October 29, 2010 Nuedexta, Otsuka America Pharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first October 10, 2017; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 4 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- August 13, 2026 Nuedexta capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $26.64 per capsule Nuedexta 20-10 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2021 0 Class I among all firms' recalls; latest March 15, 2021
- FAERS reports
- 3,617 through July 30, 2026
What is dextromethorphan and quinidine used for?
From the label: indications and usageDextromethorphan hydrobromide and quinidine sulfate capsules are 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. […]
FDA pharmacologic class: Antiarrhythmic, Cytochrome P450 2D6 Inhibitor, Sigma-1 Agonist and Uncompetitive N-methyl-D-aspartate Receptor Antagonist.
Source: FDA drug label (Dextromethorphan Hydrobromide and Quinidine Sulphate), Sun Pharmaceutical Industries, Inc., effective July 8, 2026 (SPL set 92b54ac4-594e-47b8-a4d3-394a29b425f3), via openFDA; the full label on DailyMed
Is there a generic for dextromethorphan and quinidine (Nuedexta)?
The FDA approved the first generic dextromethorphan and quinidine on October 10, 2017. 3 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists dextromethorphan and quinidine from 4 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it. In the latest NADAC survey pharmacies bought only the brand, so a generic may not be on sale yet.
The Orange Book lists 1 patent for Nuedexta capsules, the last expiring on August 13, 2026. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2010 earliest approval on file
- 2017 first generic approved
- 2026 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dextromethorphan and quinidine (Nuedexta)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $26.64 per Nuedexta 20-10 mg capsule, up 3% from $25.85 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Nuedexta 20-10 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Nuedexta 20-10 mg capsule | Brand | $26.64 per capsule | $799.06 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has dextromethorphan and quinidine been recalled?
The FDA's Enforcement Report lists 1 recall naming dextromethorphan and quinidine since 2021: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the dextromethorphan and quinidine label say about other medicines?
The dextromethorphan and quinidine label names 27 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aprepitant | warnings and precautions | Strong and moderate CYP3A inhibitors include, but are not limited to, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil. |
| Atazanavir | warnings and precautions | Strong and moderate CYP3A inhibitors include, but are not limited to, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil. |
| Clarithromycin | warnings and precautions | Strong and moderate CYP3A inhibitors include, but are not limited to, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil. |
| Clomipramine | warnings and precautions | When used with SSRIs (such as fluoxetine) or tricyclic antidepressants (such as clomipramine and imipramine), dextromethorphan hydrobromide and quinidine sulfate may cause “serotonin syndrome”, with changes including altered mental status, hypertension, restlessness, myoclonus, hyperthermia, hyperreflexia … |
| Codeine | drug interactions | In cases of prodrugs whose actions are mediated by the CYP2D6-produced metabolites (for example, codeine and hydrocodone, whose analgesic and antitussive effects appear to be mediated by morphine and hydromorphone, respectively), it may not be possible to achieve the desired clinical benefits in the presence of … |
| Desipramine | drug interactions | DRUG INTERACTIONS Desipramine: Exposure increases 8-fold. |
| Digoxin | drug interactions | Reduce paroxetine dose and adjust based on clinical response. ( 7.5 , 12.4 ) Digoxin: Increased digoxin substrate plasma concentration may occur. |
| Diltiazem | warnings and precautions | Strong and moderate CYP3A inhibitors include, but are not limited to, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil. |
| Erythromycin | warnings and precautions | Strong and moderate CYP3A inhibitors include, but are not limited to, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil. |
| Fluconazole | warnings and precautions | Strong and moderate CYP3A inhibitors include, but are not limited to, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil. |
| Fluoxetine | warnings and precautions | When used with SSRIs (such as fluoxetine) or tricyclic antidepressants (such as clomipramine and imipramine), dextromethorphan hydrobromide and quinidine sulfate may cause “serotonin syndrome”, with changes including altered mental status, hypertension, restlessness, myoclonus, hyperthermia, hyperreflexia … |
| Fosamprenavir | warnings and precautions | Strong and moderate CYP3A inhibitors include, but are not limited to, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil. |
| Hydrocodone | drug interactions | In cases of prodrugs whose actions are mediated by the CYP2D6-produced metabolites (for example, codeine and hydrocodone, whose analgesic and antitussive effects appear to be mediated by morphine and hydromorphone, respectively), it may not be possible to achieve the desired clinical benefits in the presence of … |
| Hydromorphone | drug interactions | In cases of prodrugs whose actions are mediated by the CYP2D6-produced metabolites (for example, codeine and hydrocodone, whose analgesic and antitussive effects appear to be mediated by morphine and hydromorphone, respectively), it may not be possible to achieve the desired clinical benefits in the presence of … |
Every other medicine the dextromethorphan and quinidine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Imipramine | warnings and precautions | When used with SSRIs (such as fluoxetine) or tricyclic antidepressants (such as clomipramine and imipramine), dextromethorphan hydrobromide and quinidine sulfate may cause “serotonin syndrome”, with … |
| Itraconazole | warnings and precautions | Strong and moderate CYP3A inhibitors include, but are not limited to, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin … |
| Ketoconazole | warnings and precautions | Strong and moderate CYP3A inhibitors include, but are not limited to, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin … |
| Mefloquine | contraindications | CONTRAINDICATIONS Concomitant use with quinidine, quinine, or mefloquine. ( 4.1 ) Patients with a history of quinidine, quinine or mefloquine-induced thrombocytopenia, hepatitis, or other … |
| Morphine | drug interactions | … hydrocodone, whose analgesic and antitussive effects appear to be mediated by morphine and hydromorphone, respectively), it may not be possible to achieve the desired clinical benefits in the … |
| Nefazodone | warnings and precautions | Strong and moderate CYP3A inhibitors include, but are not limited to, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin … |
| Nelfinavir | warnings and precautions | Strong and moderate CYP3A inhibitors include, but are not limited to, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin … |
| Paroxetine | drug interactions | Reduce desipramine dose and adjust based on clinical response. ( 7.5 , 12.4 ) Paroxetine: Exposure increases 2-fold. |
| Pimozide | contraindications | … prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine or pimozide). |
| Quinine | contraindications | CONTRAINDICATIONS Concomitant use with quinidine, quinine, or mefloquine. ( 4.1 ) Patients with a history of quinidine, quinine or mefloquine-induced thrombocytopenia, hepatitis, or other … |
| Ritonavir | warnings and precautions | … clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir … |
| Thioridazine | contraindications | … that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine or pimozide). |
| Verapamil | warnings and precautions | … diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil. |
Check dextromethorphan and quinidine against other medicines
Source: FDA drug label (Dextromethorphan Hydrobromide and Quinidine Sulphate), Sun Pharmaceutical Industries, Inc., effective July 8, 2026 (SPL set 92b54ac4-594e-47b8-a4d3-394a29b425f3), via openFDA; the full label on DailyMed
What do FAERS reports show for dextromethorphan and quinidine?
The FDA Adverse Event Reporting System holds 3,617 reports that list dextromethorphan and quinidine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 278 are coded as a death and 500 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other antiarrhythmics
- the pharmacologic class, with prices and generics
- Dextromethorphan and quinidine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other