United States· US:55505-196_443a0d0c-3098-4c35-97f8-8d01a7b3c83a
Nizoral
A ketoconazole product containing ketoconazole, registered in United States by Kramer Laboratories. The same ATC class is registered in 14 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
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
Ketoconazole · ATC D01AC08
14 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Germany
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- KETOCONAZOLE
- Manufacturer
- Kramer Laboratories
- 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 13, 2026
Packs & prices · 18
- ndc1155505196331 BOTTLE in 1 CARTON (55505-196-33) / 125 mL in 1 BOTTLE
- ndc1155505196401 BOTTLE in 1 CARTON (55505-196-40) / 200 mL in 1 BOTTLE
- ndc1155505196474 mL in 1 PACKET (55505-196-47)
- ndc1155505196572 BOTTLE in 1 CARTON (55505-196-57) / 200 mL in 1 BOTTLE
- ndc1155505196651 CARTON in 1 CARTON (55505-196-65) / 400 mL in 1 CARTON
- ndc1155505196683 BOTTLE in 1 CARTON (55505-196-68) / 200 mL in 1 BOTTLE
- ndc1155505196722 BOTTLE in 1 CARTON (55505-196-72) / 325 mL in 1 BOTTLE
- ndc1155505196842 BOTTLE in 1 CARTON (55505-196-84) / 400 mL in 1 BOTTLE
- ndc1155505196851 BOTTLE in 1 CARTON (55505-196-85) / 562 mL in 1 BOTTLE
- ndc1155505-196-33
- ndc1155505-196-40
- ndc1155505-196-47
- ndc1155505-196-57
- ndc1155505-196-65
- ndc1155505-196-68
- ndc1155505-196-72
- ndc1155505-196-84
- ndc1155505-196-85
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.
- United KingdomBoots Anti-Dandruff 2% shampooThe Boots Company Plc
- PolandKetoconazole HRAHRA Pharma Rare Diseases
- FranceKETOCONAZOLE ARROW 2 %, gel en récipient-unidoseARROW GENERIQUES
- SpainFUNGAREST 20 mg/g cremaLaboratorio Stada S.L.
- FinlandCanizol vetDechra Regulatory B.V.
- SwitzerlandKeto-med Shampoo
- NetherlandsKetoconazol Aurobindo Shampoo 20 mg/g, shampooAurobindo Pharma B.V.
- GermanyKetoconazol KlingeAenova Ip Gmbh
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/af5c10c8-73ce-4de0-b243-b99125de430a GET /v1/drugs/af5c10c8-73ce-4de0-b243-b99125de430a?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": "10",
"substance": "KETOCONAZOLE",
"productndc": "55505-196",
"dosage_form": "SHAMPOO",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "NDA020310",
"marketing_category": "NDA"
}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.