United States· US:54482-020_0ae95603-411c-455b-8bb8-8c5b01dac297
CYSTARAN
A medicinal product containing cysteamine hydrochloride, registered in United States by Leadiant Biosciences, Inc..
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
- CYSTEAMINE HYDROCHLORIDE
- Manufacturer
- Leadiant Biosciences, Inc.
- 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
- ndc11544820200215 mL in 1 BOTTLE (54482-020-02)
- ndc1154482-020-02
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Cysteamine hydrochloride in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomCystadrops 3.8mg/ml eye dropsRecordati Rare Diseases UK Ltd
- CzechiaCYSTADROPSRecordati Rare Diseases, Puteaux
- IrelandCystadrops 3.8 mg/mL eye drops solutionRecordati Rare Diseases
- PolandCystadropsRecordati Rare Diseases
- SwedenCystadrops 3,8 mg/ml Ögondroppar, lösningRecordati Rare Diseases
- FinlandCystadropsRecordati Rare Diseases
- BelgiumCystadrops 3.8 mg/mlRecordati Rare Diseases
- IcelandCYSTADROPSRecordati Rare Diseases*
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Cystadrops, Cystagon
- Liechtenstein · Cystadrops, Cystagon
- Norway · Cystadrops, Cystagon
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/59a759d5-3b67-46b3-a5e6-8fcbfc777e55 GET /v1/drugs/59a759d5-3b67-46b3-a5e6-8fcbfc777e55?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": "OPHTHALMIC",
"source": "ndc",
"strength": "6.5",
"substance": "CYSTEAMINE HYDROCHLORIDE",
"productndc": "54482-020",
"dosage_form": "SOLUTION",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "NDA200740",
"marketing_category": "NDA"
}See everything about cysteamine hydrochloride.
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.