Drug Database
Back to search

United States· US:69051-300_463f0c82-b948-2b96-e063-6394a90aecf0

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.

ATC P01CX04Orange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedIMPAVIDOATCP01CX04REGISTER NO.US:69051-300_463f0c82…PACKS LISTED1CHECKEDSeptember 12, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about miltefosineAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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
Search miltefosine products by name

Miltefosine · ATC P01CX04

6 / 19 countries

  • Czechiaprice
  • Finlandprice
  • Germany
  • Norwayprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

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 12, 2026

Packs & prices · 1

  • ndc11
    6905130001
    2 BLISTER PACK in 1 CARTON (69051-300-01) / 14 CAPSULE in 1 BLISTER PACK

Regulatory notes

UNII (FDA substance ID)
53EY29W7EC
MILTEFOSINE
RxCUI 1494066
Orange Book
N204684
DailyMed SPL labels
1 version tracked

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
Check miltefosine against other medicinesHow interaction checks work

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.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

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.

All miltefosine products

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/f75a71d9-512c-4936-824e-a3488f59ed66
GET /v1/drugs/f75a71d9-512c-4936-824e-a3488f59ed66?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.

{
  "unii": {
    "unii": "53EY29W7EC",
    "rxcui": "1494066",
    "inchikey": "PQLXHQMOHUQAKB-UHFFFAOYSA-N",
    "display_name": "MILTEFOSINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 5
  },
  "spl_meta": {
    "bcb387ac-2e90-4f5e-94b2-d3635190678e": {
      "match": "brand_token",
      "title": "IMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]",
      "spl_version": "13",
      "published_date": "2026-02-11"
    }
  },
  "productid": "69051-300_463f0c82-b948-2b96-e063-6394a90aecf0",
  "productndc": "69051-300",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "204684",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Mar 19, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MILTEFOSINE",
  "proprietary_name": "IMPAVIDO",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA204684",
  "marketing_category": "NDA",
  "nonproprietary_name": "miltefosine",
  "start_marketing_date": "20151029",
  "active_numerator_strength": "50"
}
API referenceMCP serverPlans

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.

Try it freeOpen in the console