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United States· US:45802-532_f9768109-216c-49f3-be2a-d0c3eac142b9

ketoconazole

A ketoconazole product containing ketoconazole, registered in United States by Padagis Israel Pharmaceuticals Ltd. The same ATC class is registered in 14 of our 19 countries.

ATC D01AC08US 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…normalisedketoconazoleATCD01AC08REGISTER NO.US:45802-532_f9768109…PACKS LISTED4CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about ketoconazoleAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Ketoconazole is registered in 14 of 19 countries.

Countries holding a registration under ATC D01AC08 (ketoconazole), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 8 of them publish a price we can compare per daily dose
Search ketoconazole products by name

Ketoconazole · ATC D01AC08

14 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Germany
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • 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
KETOCONAZOLE
Manufacturer
Padagis Israel Pharmaceuticals Ltd
Country
United States (US)
ATC code
D01AC08
ATC class
Ketoconazole
Defined daily dose
30 mg, T
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 4

  • ndc11
    4580253232
    1 CANISTER in 1 CARTON (45802-532-32) / 50 g in 1 CANISTER
  • ndc11
    4580253233
    1 CANISTER in 1 CARTON (45802-532-33) / 100 g in 1 CANISTER
  • ndc11
    45802-532-32
  • ndc11
    45802-532-33

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Ketoconazole in 16 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All ketoconazole products

Authorised across Europe · EMA

The same active substance is authorised in 31 EEA countries. Names it is sold under:

  • Austria · Fungoral, Nizoral
  • Belgium · Nizoral
  • Bulgaria · Ketoderm, Nizoral
  • Cyprus · Ilgem Med, Nizoral
  • Czechia · Ketokonazol Dr.Max, Nizoral
  • Germany · Ketoconazol Klinge, Ketozolin
  • Denmark · Ketoconazole Actavis, Nizoral
  • Estonia · Ketoconazol Ratiopharm, Mikanisal
  • Spain · Fungarest, Keto-Cure
  • Finland · Ketoconazol Ratiopharm, Ketoconazole Stada
  • France · Kapanek, Ketoconazole Arrow
  • United Kingdom (Northern Ireland) · Daktarin Gold, Daktarin Intensiv
  • Greece · Botaderm, Ebersept
  • Croatia · Oronazol
  • Hungary · Nizoral, Nizoral Korpásodás Ellen
  • Ireland · Ketoconazole Pinewood Laboratories, Nizoral
  • Iceland · Dermatín, Fungoral
  • Italy · Ketonova, Nizoblue
  • Liechtenstein · Ketoconazole Esteve
  • Lithuania · Ketoconazol Ratiopharm, Nizoral
  • Luxembourg · Nizoral
  • Latvia · Ketoconazol Ratiopharm, Mikanisal
  • Malta · Nizoral
  • Netherlands · Ketoconazol Cf, Ketoconazol Double-E Pharma
  • Norway · Fungoral, Ketoconazole Esteve
  • Poland · Ketoconazole Hasco, Nizax Activ
  • Portugal · Cetoconazol Folicalm, Nizoral
  • Romania · Ketoconazol Dr. Max, Ketoconazol Dr.Max
  • Sweden · Fungoral, Ketoconazol Actavis
  • Slovenia · Oronazol
  • Slovakia · Ketoconazol Dr. Max, Nizoral

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/f45cec91-5883-4269-bed1-b22fa8f938c4
GET /v1/drugs/f45cec91-5883-4269-bed1-b22fa8f938c4?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": "2",
  "substance": "KETOCONAZOLE",
  "productndc": "45802-532",
  "dosage_form": "AEROSOL, FOAM",
  "dea_schedule": null,
  "strength_unit": "g/100g",
  "application_number": "ANDA091550",
  "marketing_category": "ANDA"
}
API referenceMCP serverPlans

See everything about ketoconazole.

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.

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