Quick answers
- What is Nuedexta?
- Nuedexta is a brand name of Dextromethorphan hydrobromide and quinidine sulfate, a prescription medicine. The FDA NDC Directory lists 2 Nuedexta products in 1 strength and form.
- Who makes Nuedexta?
- Otsuka America Pharm holds the FDA application for Nuedexta (NDA021879, approved October 29, 2010). 1 other company (repackagers or distributors) also list Nuedexta products.
- Is there a generic or store brand of Nuedexta?
- Other products of Dextromethorphan hydrobromide and quinidine sulfate are listed with the FDA, but none in exactly the same strength and form as a Nuedexta product.
- What do pharmacies pay for Nuedexta?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 1 Nuedexta strength and form (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has Nuedexta been recalled?
- FDA enforcement reports list 1 recall of Nuedexta products; the newest started March 15, 2021. A recall usually concerns specific lots, not every product.
What Nuedexta is
Each Nuedexta product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Dextromethorphan hydrobromide and quinidine sulfate · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| dextromethorphan hydrobromide 20 mg · quinidine sulfate 10 mg capsule, gelatin coated (oral) | Nuedexta | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Dextromethorphan hydrobromide and quinidine sulfate →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA021879 | Otsuka America Pharm | October 29, 2010 | 2 |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| dextromethorphan hydrobromide 20 mg · quinidine sulfate 10 mg capsule, gelatin coated | Brand: Nuedexta | $26.58 per capsule |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list Nuedexta
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Nuedexta products.
- Avanir Pharmaceuticals, Inc.1 product
- Otsuka America Pharmaceutical, Inc1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 15, 2021 · Class II · Terminated · D-0442-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Nuedexta (dextromethorphan HBr and quinidine sulfate) Capsules 20 mg/10 mg 60 capsules Rx only NDC 64597-301-60 Manufactured by Patheon, Inc. Whitby, ON L1N 5Z5, Canada — Cardinal Health Inc.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.