United States· US:0378-9045_29dfd298-96ed-4a5f-a573-b24f5ffa618b
Cystagon
A medicinal product containing cysteamine bitartrate, registered in United States by Mylan Pharmaceuticals 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
- Mylan Pharmaceuticals 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
- ndc110378904505500 CAPSULE in 1 BOTTLE, PLASTIC (0378-9045-05)
- ndc110378-9045-05
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.
- CzechiaCYSTAGONRecordati Rare Diseases, Puteaux
- IrelandCYSTAGON 150 mg hard capsulesRecordati Rare Diseases
- FinlandCystagonRecordati Rare Diseases
- FranceCYSTAGON 150 mg, géluleRECORDATI RARE DISEASES
- United KingdomCystagon 150mg capsulesRecordati Rare Diseases UK Ltd
- IcelandCystagonRecordati Rare Diseases*
- NorwayCystagonRecordati Rare Diseases
- PolandCystagonRecordati 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/1f3bebc9-b5e9-4adf-9c35-ee488d323161 GET /v1/drugs/1f3bebc9-b5e9-4adf-9c35-ee488d323161?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": "150",
"substance": "CYSTEAMINE BITARTRATE",
"productndc": "0378-9045",
"dosage_form": "CAPSULE",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA020392",
"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.