United States· US:55292-410_34dba967-28b4-4fc8-876d-2e30d32a0f95

CYSTADROPS

A medicinal product containing cysteamine hydrochloride, registered in United States by RECORDATI RARE DISEASES, INC..

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedCYSTADROPSATC—REGISTER NO.US:55292-410_34dba967…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
CYSTEAMINE HYDROCHLORIDE
Manufacturer
RECORDATI RARE DISEASES, 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

  • ndc11
    5529241005
    1 BOTTLE, GLASS in 1 BOX (55292-410-05) / 5 mL in 1 BOTTLE, GLASS
  • ndc11
    55292-410-05

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.

All cysteamine hydrochloride products

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/42a94e8a-cd5e-4bab-a3f4-d490582a08d8
GET /v1/drugs/42a94e8a-cd5e-4bab-a3f4-d490582a08d8?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": "3.5",
  "substance": "CYSTEAMINE HYDROCHLORIDE",
  "productndc": "55292-410",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "NDA211302",
  "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.