ELMIRON
Active substance: pentosan polysulfate
CAPSULE, GELATIN COATED · PENTOSAN POLYSULFATE SODIUM 100 mg/1
United StatesActive
Marketing holder: Janssen Pharmaceuticals, Inc.
Verified 2026-10-09 · openFDA NDC
Analogues in other countries- Source: openFDA NDC
- Countries with the substance registered: 2
Composition
- PENTOSAN POLYSULFATE SODIUM · 100 mg/1
Analogues by country
Products with the same active substance registered in other countries.
| Country | Products |
|---|---|
| EU 1 |
|
Import and control
Control by country
- United Statesprescription only
Source: openFDA NDC · record 01a1208e-614b-754a-8e4a-9f522a29a370;count=1 · valid from 2026-10-09 · verified 2026-10-09
Registration
- Registration number
- 50458-098
- Registration status
- Active
- Dispensing
- Prescription only
- Route
- ORAL
Sources
- product · openFDA NDC · 50458-098 · Verified 2026-10-09 · open in source
- registration_status · openFDA NDC · 50458-098 · Verified 2026-10-09 · open in source
- ingredients.0 · openFDA NDC · 50458-098 · Verified 2026-10-09 · open in source