United States· US:64380-827_9781ff7c-39a7-4c61-a6ec-7f1947685c6b
KETOCONAZOLE
A medicinal product containing ketoconazole, registered in United States by Strides Pharma Science Limited.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- KETOCONAZOLE
- Manufacturer
- Strides Pharma Science Limited
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 4
- ndc116438082706100 TABLET in 1 BOTTLE (64380-827-06)
- ndc116438082707500 TABLET in 1 BOTTLE (64380-827-07)
- ndc1164380-827-06
- ndc1164380-827-07
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 KingdomKetoconazole 200mg tabletsA A H Pharmaceuticals Ltd
- FinlandCanizol vetDechra Regulatory B.V.
- CanadaAPO-KETOCONAZOLEAPOTEX INC
- PolandKetoconazole HRAHRA Pharma Rare Diseases
- IrelandKetoconazole Esteve 200 mg tabletsEsteve Pharmaceuticals S.A.
- IcelandKetoconazole EsteveEsteve Pharmaceuticals S.A.
- NetherlandsKetoconazole Esteve, 200 mg tablettenEsteve Pharmaceuticals S.A.
- NorwayKetoconazole EsteveEsteve Pharmaceuticals S.A
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/ba93486f-eb8d-4ce8-819e-45a8a12c5c49 GET /v1/drugs/ba93486f-eb8d-4ce8-819e-45a8a12c5c49?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": "200",
"substance": "KETOCONAZOLE",
"productndc": "64380-827",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA210457",
"marketing_category": "ANDA"
}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.