United States· US:69315-164_3706a800-8ea5-4593-9c7b-5083978b559b
HYDROXYUREA
A medicinal product containing hydroxyurea, registered in United States by Leading Pharma, LLC.
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
- Leading Pharma, LLC
- 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
- ndc116931516401100 CAPSULE in 1 BOTTLE, PLASTIC (69315-164-01)
- ndc1169315-164-01
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.
- United KingdomHydrea 500mg capsulesWaymade Healthcare Plc
- FinlandHydreaOrifarm Oy
- NetherlandsHydroxycarbamide Devatis 500mg, harde capsulesDevatis GmbH
- SwitzerlandHydroxycarbamid Devatis
- NorwayHydreaCheplapharm
- CanadaAPO-HYDROXYUREAAPOTEX INC
- PolandHydroxycarbamid EugiaEugia Pharma (Malta) Ltd.
- SwedenHydrea 500 mg Kapsel, hårdCheplapharm Arzneimittel GmbH
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/b932ad03-5919-470a-b7cd-4321a4a06ef8 GET /v1/drugs/b932ad03-5919-470a-b7cd-4321a4a06ef8?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": "500",
"substance": "HYDROXYUREA",
"productndc": "69315-164",
"dosage_form": "CAPSULE",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA213438",
"marketing_category": "ANDA"
}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.