United States· US:65162-087_fabca3d3-1b0c-48a3-bd56-5e5a11b1fb3b

Itraconazole

A itraconazole product containing itraconazole, registered in United States by Amneal Pharmaceuticals LLC. The same ATC class is registered in 16 of our 19 countries.

ATC J02AC02US 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…normalisedItraconazoleATCJ02AC02REGISTER NO.US:65162-087_fabca3d3…PACKS LISTED4CHECKEDAugust 16, 2026

Where it is registered

Itraconazole is registered in 16 of 19 countries.

Countries holding a registration under ATC J02AC02 (itraconazole), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 10 of them publish a price we can compare per daily dose

Itraconazole · ATC J02AC02

16 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Italyprice
  • 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.

Price per daily dose

What a daily dose of itraconazole costs, country by country.

Normalised to the WHO defined daily dose (0.2 g), the median price runs from $2.13 in Italy to $5.76 in Switzerland — a ×2.7 gap.

  • 2 markets with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown

Itraconazole · price per daily dose (0.2 g)

USD · FX 28 Sept 2026

  • CH Switzerland$5.76
  • IT Italy$2.13
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
ITRACONAZOLE
Manufacturer
Amneal Pharmaceuticals LLC
Country
United States (US)
ATC code
J02AC02
ATC class
Itraconazole
Defined daily dose
0.2 g, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
August 16, 2026

Packs & prices · 4

  • ndc11
    6516208734
    10 CUP, UNIT-DOSE in 1 TRAY (65162-087-34) / 10 mL in 1 CUP, UNIT-DOSE (65162-087-13)
  • ndc11
    6516208774
    150 mL in 1 BOTTLE, GLASS (65162-087-74)
  • ndc11
    65162-087-34
  • ndc11
    65162-087-74

Regulatory notes

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

Interactions

456 interactions on record for itraconazole.

Graded by severity as the source publishes them — 135 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

Itraconazole · interactions on record

456 records

  • 135 severe
  • 164 moderate
  • 31 minor
  • 85 info

Most severe, free to view

  • CisaprideA03FA02severe
  • NaloxegolA06AH03severe
  • LoperamideA07DA03severe
  • BudesonideA07EA06severe

41 more interactions with mechanism and management, from a commercially licensed source.

Sign in to check
  • 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

Itraconazole in 16 other countries

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

All itraconazole products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Itraconazol Sandoz, Itraconazol Stada
  • Belgium · Itraconazol Ab, Itraconazol Sandoz
  • Bulgaria · Итраназол Адифарм, Фунгизол
  • Cyprus · Flunol, Neo-Candimyk®
  • Czechia · Conisor, Prokanazol
  • Germany · Itraconazol 1 A Pharma, Itraconazol Al
  • Denmark · Itraconazol Stada, Niddazol
  • Estonia · Cladosol, Itraconazol Actavis
  • Spain · Canadiol, Hongoseril
  • Finland · Sporanox
  • France · Itraconazole Sandoz, Itraconazole Teva
  • United Kingdom (Northern Ireland) · Itraconazole Accord Healthcare, Itraconazole Focus Pharmaceuticals Ltd
  • Greece · Assosept-S, Deratil
  • Croatia · Itrac
  • Hungary · Itraconazol Medico Uno, Omicral
  • Ireland · Itraconazole Athlone Pharmaceuticals, Sporanox
  • Iceland · Sporanox
  • Italy · Itraconazolo Doc Generici, Itraconazolo Eg
  • Lithuania · Cladosol, Itraconazol Actavis
  • Luxembourg · Itraconazole Eg, Sporanox
  • Latvia · Cladosol, Itraconazol Actavis
  • Malta · Itraconazol Slavia, Itraconazole Sugar Free Syri Pharma
  • Netherlands · Itraconazol Ascend, Itraconazol Cf
  • Norway · Sporanox
  • Poland · Ipozumax, Itrax
  • Portugal · Fungizol, Itraconazol Alter
  • Romania · Itraconazol Arena, Itraconazol Slavia
  • Sweden · Itrakonazol Actavis, Itrakonazol Stada
  • Slovenia · Sporanox
  • Slovakia · Prokanazol, Sporanox

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/e8ae0259-2eab-42ca-946c-c46361bf01a5
GET /v1/drugs/e8ae0259-2eab-42ca-946c-c46361bf01a5?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",
  "substance": "ITRACONAZOLE",
  "productndc": "65162-087",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "ANDA205573",
  "marketing_category": "ANDA"
}

See everything about itraconazole.

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.