United States· US:71770-105_47d0b61d-ad65-d2e0-e063-6294a90afe50
Siklos
A medicinal product containing hydroxyurea, registered in United States by Medunik.
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
- HYDROXYUREA
- Manufacturer
- Medunik
- 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 · 2
- ndc1171770105601 BOTTLE in 1 CARTON (71770-105-60) / 60 TABLET, FILM COATED in 1 BOTTLE
- ndc1171770-105-60
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Hydroxyurea in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaSIKLOSTHERAVIA, Neuilly-sur-Seine
- SpainSIKLOS 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULATheravia
- FinlandSiklosTheravia
- FranceSIKLOS 100 mg, comprimé pelliculé sécableTHERAVIA
- IrelandSiklos 100 mg film-coated tabletTheravia
- IcelandSiklosTheravia
- NetherlandsSiklos filmomhulde tabletten, 100 mgTheravia
- NorwaySiklosTheravia
Authorised across Europe · EMA
The same active substance is authorised in 31 EEA countries. Names it is sold under:
- Austria · Ardjaq, Hydroxycarbamid Devatis
- Belgium · Hydrea
- Bulgaria · Хидреа
- Cyprus · Hydreasyn
- Czechia · Litalir
- Germany · Ardjaq, Hydroxycarbamid 1 A Pharma
- Denmark · Hydroxyurea Medac, Oribamide
- Estonia · Hydrea
- Spain · Hidroxicarbamida Hikma, Hidroxicarbamida Medac
- Finland · Hydrea, Hydroxyurea Medac
- France · Hydrea, Hydroxycarbamide Arrow
- United Kingdom (Northern Ireland) · Hydrea, Hydroxycarbamide
- Greece · Hydreasyn
- Croatia · Litalir, Xybaid
- Hungary · Hydroxycarbamide Pharmacenter, Litalir
- Ireland · Hydrea
- Iceland · Hydroxyurea Medac, Siklos
- Italy · Idrossicarbamide Aurobindo, Onco Carbide
- Liechtenstein · Siklos
- Lithuania · Hydrea
- Luxembourg · Hydrea, Hydroxycarbamid Devatis
- Latvia · Hydrea
- Malta · Hydroxycarbamide Eugia
- Netherlands · Hydroxycarbamide Devatis, Hydroxycarbamide Eugia
- Norway · Hydroxyurea Medac, Oribamide
- Poland · Hydroxycarbamid Eugia, Hydroxycarbamid Teva
- Portugal · Hidroxicarbamida Generis, Hidroxicarbamida Hikma
- Romania · Hydrea
- Sweden · Hydrea, Hydroxyurea Medac
- Slovenia · Hidroksisečnina Aptapharma, Litalir
- Slovakia · Hydroxykarbamid Medac, Xybaid
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/204d51f6-45f1-4f76-8aca-8f7c9dce765d GET /v1/drugs/204d51f6-45f1-4f76-8aca-8f7c9dce765d?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": "100",
"substance": "HYDROXYUREA",
"productndc": "71770-105",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA208843",
"marketing_category": "NDA"
}See everything about hydroxyurea.
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.