United States· US:63629-2184_aaf58415-1e55-4d24-ae46-d16708f4c0b7
Doxylamine Succinate and Pyridoxine Hydrochloride
A medicinal product containing doxylamine succinate; pyridoxine hydrochloride, registered in United States by Bryant Ranch Prepack.
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
- DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
- Manufacturer
- Bryant Ranch Prepack
- 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 · 2
- ndc1163629-2184-1
- ndc116362921841100 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-2184-1)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Doxylamine succinate; pyridoxine hydrochloride in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaXONVEAExeltis Czech s.r.o., Praha
- PolandXonveaExeltis Poland Sp. z o.o.
- SwitzerlandBonjesta
- IrelandCariban 10 mg/10 mg modified-release hard capsulesItalfarmaco S.p.A.
- CanadaALOG-DOXYLAMINE/PYRIDOXINEANALOG PHARMA CANADA INC.
- SpainBONJESTA 10 MG/10 MG COMPRIMIDOS GASTRORRESISTENTESExeltis Healthcare S.L.
- NetherlandsEmbagyn 20 mg/20 mg tabletten met gereguleerde afgifteExeltis Healthcare S.L
- FinlandBonjestaExeltis Healthcare S.L.
Authorised across Europe · EMA
The same active substance is authorised in 27 EEA countries. Names it is sold under:
- Austria · Nuperal, Xonvea
- Belgium · Bonjesta, Navalit
- Bulgaria · Нюперал
- Cyprus · Nuperal
- Czechia · Nuperal, Xonvea
- Germany · Cariban, Cariban 10 Mg/10 Mg
- Denmark · Bonjesta, Xonvea
- Estonia · Xonvea
- Spain · Bonjesta, Cariban
- Finland · Bonjesta, Xonvea
- France · Cariban, Xonvea
- United Kingdom (Northern Ireland) · Xonvea
- Greece · Nuperal
- Hungary · Nuperal, Vombee
- Ireland · Cariban, Doxpirexel
- Iceland · Xonvea
- Italy · Bonjesta, Embagyn
- Lithuania · Xonvea
- Luxembourg · Bonjesta, Bonjesta 20/20
- Latvia · Xonvea
- Netherlands · Embagyn, Navalit
- Norway · Embagyn, Xonvea
- Poland · Bonjesta, Xonvea
- Portugal · Bonjesta, Cariban
- Romania · Nuperal
- Sweden · Bonjesta, Xonvea
- Slovakia · Nuperal, Xonvea
Source: European Medicines Agency, Article 57 product data.
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/0751be11-1534-48c0-a862-6f629b73b385 GET /v1/drugs/0751be11-1534-48c0-a862-6f629b73b385?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": "10; 10",
"substance": "DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE",
"productndc": "63629-2184",
"dosage_form": "TABLET, DELAYED RELEASE",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "ANDA208518",
"marketing_category": "ANDA"
}See everything about doxylamine succinate; pyridoxine hydrochloride.
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.