United States· US:75987-101_374233b1-345c-4d9e-9bc0-e5aa2f9d8e1f
PROCYSBI
A medicinal product containing cysteamine bitartrate, registered in United States by Horizon Therapeutics USA, 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 BITARTRATE
- Manufacturer
- Horizon Therapeutics USA, Inc.
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- June 26, 2026
Packs & prices · 2
- ndc117598710108250 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (75987-101-08)
- ndc1175987-101-08
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Cysteamine bitartrate 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/c95b90f4-3ecc-4ff0-ab67-5fc903066c9d GET /v1/drugs/c95b90f4-3ecc-4ff0-ab67-5fc903066c9d?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": "75",
"substance": "CYSTEAMINE BITARTRATE",
"productndc": "75987-101",
"dosage_form": "CAPSULE, DELAYED RELEASE PELLETS",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA203389",
"marketing_category": "NDA"
}See everything about cysteamine bitartrate.
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.