Medicine
Nuedexta 20 mg/10 mg capsule
Nuedexta 20 mg/10 mg capsule is a prescription medicine containing Dextromethorphan and Quinidine for oral use, marketed by Otsuka America Pharmaceutical, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store NUEDEXTA capsules at controlled room temperature, 25°C (77°F)…
Key facts
- Active ingredient (INN)
- Dextromethorphan and Quinidine
- Brand
- Nuedexta
- Strength
- 20 mg/10 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 60 capsules, 4 cartons
- Marketing authorisation holder
- Otsuka America Pharmaceutical
- Manufacturer
- Otsuka America Pharmaceutical2 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store NUEDEXTA capsules at controlled room temperature, 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [ s ee USP Controlled Room Temperature].
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N07XX59 Dextromethorphan and Quinidine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 December 2010
- Identifiers
- RxCUI 1040054, 1040058DailyMed set ID c8cce784-8c5f-415b-8068-76e5d481d159, 484e0918-3442-49dc-8ccf-177f1f3ee9f3NDC 59148-053, 64597-301Application NDA021879
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 60 capsule, gelatin coated in 1 bottle | 59148-053-16 | Otsuka America Pharmaceutical | 3 January 2023 |
| 4 carton in 1 box / 1 bottle in 1 carton / 13 capsule, gelatin coated in 1 bottle | 59148-053-98 | Otsuka America Pharmaceutical | 3 January 2023 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Dextromethorphan and Quinidine 20 mg/10 mg capsule.
Clinical summary
Dextromethorphan and Quinidine is a fixed-dose combination of an antiarrhythmic, a cytochrome P450 2D6 inhibitor and a sigma-1 agonist indicated for the treatment of pseudobulbar affect (PBA). It is available as capsules for oral use. MedsAcross supplies Dextromethorphan and Quinidine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Dextromethorphan and QuinidineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Nuedexta prescribing information (Otsuka America Pharmaceutical) · U.S. National Library of Medicine, DailyMed
Need Nuedexta 20 mg/10 mg capsule for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.