Medicine
Elmiron 100 mg capsule
Elmiron 100 mg capsule is a prescription medicine containing Pentosan polysulfate for oral use, marketed by Janssen Pharmaceuticals, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20 °C to 25 °C (68 °F to 77 °F), excursions permitted to 15 °C to 30…
Key facts
- Active ingredient (INN)
- Pentosan polysulfate
- Brand
- Elmiron
- Strength
- 100 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules
- Marketing authorisation holder
- Janssen Pharmaceuticals
- Manufacturer
- Janssen Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20 °C to 25 °C (68 °F to 77 °F), excursions permitted to 15 °C to 30 °C (59 °F to 86 °F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G04BX15 Pentosan polysulfate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 26 September 1996
- Identifiers
- RxCUI 199498, 211140DailyMed set ID f0ba651e-3d8a-11df-8fbe-119855d89593NDC 50458-098Application NDA020193
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 capsule, gelatin coated in 1 bottle | 50458-098-01 | Janssen Pharmaceuticals | 26 September 1996 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Pentosan polysulfate is a glycosaminoglycan indicated for the relief of bladder pain or discomfort associated with interstitial cystitis. It is available as capsules for oral use. MedsAcross supplies Pentosan polysulfate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Pentosan polysulfateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ELMIRON prescribing information (Janssen Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Elmiron: European public assessment report (EPAR) · European Medicines Agency
Need Elmiron 100 mg capsule for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.