United States· US:0378-8123_d08db934-a9ce-4b1a-9ca1-5c6705b227a1
Zonalon
A doxepin product containing doxepin hydrochloride, registered in United States by Mylan Pharmaceuticals Inc.. The same ATC class is registered in 2 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Doxepin is registered in 2 of 19 countries.
Countries holding a registration under ATC D04AX01 (doxepin), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 1 of them publish a price we can compare per daily dose
Doxepin · ATC D04AX01
2 / 19 countries
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- DOXEPIN HYDROCHLORIDE
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Country
- United States (US)
- ATC code
- D04AX01
- ATC class
- Doxepin
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 4
- ndc1103788123301 TUBE in 1 CARTON (0378-8123-30) / 30 g in 1 TUBE
- ndc1103788123451 TUBE in 1 CARTON (0378-8123-45) / 45 g in 1 TUBE
- ndc110378-8123-30
- ndc110378-8123-45
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
591 interactions on record for doxepin.
Graded by severity as the source publishes them — 127 severe. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Doxepin · interactions on record
591 records
- 127 severe
- 448 moderate
- 16 minor
Most severe, free to view
- PapaverineA03AD01severe
- CisaprideA03FA02severe
- OndansetronA04AA01severe
- GranisetronA04AA02severe
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Doxepin in 4 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- GermanyAponal AmpullenCheplapharm Arzneimittel Gmbh
- FinlandDoxalOrion Corporation
- BelgiumSinequan 25 mgPfizer
- NorwayDoxepin tevaTeva
Authorised across Europe · EMA
The same active substance is authorised in 5 EEA countries. Names it is sold under:
- Germany · Aponal Ampullen, Aponal Tropfen
- France · Quitaxon
- United Kingdom (Northern Ireland) · Doxepin Zentiva Pharma, Xepin
- Poland · Doxepin Teva
- Romania · Doxepin Terapia
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/63a4d47d-a085-427a-acb5-ae3003b6b464 GET /v1/drugs/63a4d47d-a085-427a-acb5-ae3003b6b464?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": "TOPICAL",
"source": "ndc",
"strength": "50",
"substance": "DOXEPIN HYDROCHLORIDE",
"productndc": "0378-8123",
"dosage_form": "CREAM",
"dea_schedule": null,
"strength_unit": "mg/g",
"application_number": "NDA020126",
"marketing_category": "NDA"
}See everything about doxepin.
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.