United States· US:69051-300_535b996e-878f-4189-e063-6394a90a49bb
IMPAVIDO
A miltefosine product containing miltefosine, registered in United States by Profounda, Inc.. The same ATC class is registered in 6 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Miltefosine is registered in 6 of 19 countries.
Countries holding a registration under ATC P01CX04 (miltefosine), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 4 of them publish a price we can compare per daily dose
Miltefosine · ATC P01CX04
6 / 19 countries
- Czechiaprice
- Finlandprice
- Germany
- Norwayprice
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- MILTEFOSINE
- Manufacturer
- Profounda, Inc.
- Country
- United States (US)
- ATC code
- P01CX04
- ATC class
- Miltefosine
- Defined daily dose
- 0.15 g, O
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 1
- ndc1169051-300-01
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
16 interactions on record for miltefosine.
Graded by severity as the source publishes them — 16 moderate. 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
Miltefosine · interactions on record
16 records
- 16 moderate
Most severe, free to view
- IUP aus Plastik mit GestagenG02BA03moderate
- Levonorgestrel and ethinylestradiolG03AA07moderate
- Desogestrel and ethinylestradiolG03AA09moderate
- Drospirenone and ethinylestradiolG03AA12moderate
- 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
Miltefosine in 5 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaIMPAVIDO
- United KingdomImpavido 50mg capsulesImported (Germany)
- NorwayImpavidoPaesel + Lorei
- FinlandMilteforan
- GermanyImpavidoPaesel + Lorei Gmbh & Co. Kg
Authorised across Europe · EMA
The same active substance is authorised in 1 EEA country. Names it is sold under:
- Germany · Impavido
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/5570cd01-cee8-4762-a85c-c8b57cb6c68b GET /v1/drugs/5570cd01-cee8-4762-a85c-c8b57cb6c68b?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": "50",
"substance": "MILTEFOSINE",
"productndc": "69051-300",
"dosage_form": "CAPSULE",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA204684",
"marketing_category": "NDA"
}See everything about miltefosine.
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.