United States· US:50458-098_2268b774-ecba-3038-e063-6394a90a9210
ELMIRON
A medicinal product containing pentosan polysulfate sodium, registered in United States by Janssen 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
- PENTOSAN POLYSULFATE SODIUM
- Manufacturer
- Janssen 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
- ndc115045809801100 CAPSULE, GELATIN COATED in 1 BOTTLE (50458-098-01)
- ndc1150458-098-01
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Pentosan polysulfate sodium in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SpainELMIRON 100 MG CAPSULAS DURASBene-Arzneimittel Gmbh
- United KingdomElmiron 100mg capsulesSovereign Medical Ltd
- CzechiaELMIRONbene-Arzneimittel GmbH, Mnichov
- FinlandCartrophen Equine Forte
- CanadaCARTROPHEN VET INJ.SC 100MG/MLBIOPHARM AUSTRALIA PTY LTD.
- PolandElmironbene Arzneimittel GmbH
- BelgiumElmiron 100 mgBene-Arzneimittel
- Swedenelmiron 100 mg Kapsel, hårdbene Arzneimittel GmbH
Authorised across Europe · EMA
The same active substance is authorised in 9 EEA countries. Names it is sold under:
- Czechia · Thrombocid
- Germany · Thrombocid
- Spain · Thrombocid, Thrombocid Forte
- Hungary · Dimovena, Sp 54
- Iceland · Elmiron
- Italy · Fibrase
- Liechtenstein · Elmiron
- Norway · Elmiron
- Portugal · Comfora, Thrombocid
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/5d665e07-cea4-4cbe-a8d6-4e6492a50d8e GET /v1/drugs/5d665e07-cea4-4cbe-a8d6-4e6492a50d8e?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": "100",
"substance": "PENTOSAN POLYSULFATE SODIUM",
"productndc": "50458-098",
"dosage_form": "CAPSULE, GELATIN COATED",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA020193",
"marketing_category": "NDA"
}See everything about pentosan polysulfate sodium.
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.