United States· US:59148-053_b73848d5-ceb2-482a-99bd-a2b6b895abae
Nuedexta
A medicinal product containing dextromethorphan hydrobromide; quinidine sulfate, registered in United States by Otsuka America Pharmaceutical, Inc.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE
- Manufacturer
- Otsuka America Pharmaceutical, Inc
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 4
- ndc11591480531660 CAPSULE, GELATIN COATED in 1 BOTTLE (59148-053-16)
- ndc1159148053984 CARTON in 1 BOX (59148-053-98) / 1 BOTTLE in 1 CARTON (59148-053-07) / 13 CAPSULE, GELATIN COATED in 1 BOTTLE
- ndc1159148-053-16
- ndc1159148-053-98
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Dextromethorphan hydrobromide; quinidine sulfate in 1 other country
What each register calls a product with the same active substance — salts and hydrates count as the same.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/98a34b69-1ff5-4e42-ae69-b527073e2f1b GET /v1/drugs/98a34b69-1ff5-4e42-ae69-b527073e2f1b?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "ORAL",
"source": "ndc",
"strength": "20; 10",
"substance": "DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE",
"productndc": "59148-053",
"dosage_form": "CAPSULE, GELATIN COATED",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "NDA021879",
"marketing_category": "NDA"
}See everything about dextromethorphan hydrobromide; quinidine sulfate.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.