Ibsrela 53.2 mg tablet is a prescription medicine containing Tenapanor for oral use, marketed by Ardelyx, 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 room temperature, between 68°F to 77°F (20°C to 25°C). Keep in…
Key facts
- Active ingredient (INN)
- Tenapanor
- Brand
- Ibsrela
- Strength
- 53.2 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 6 tablets, 60 tablets
- Marketing authorisation holder
- Ardelyx
- Manufacturer
- Ardelyx
- Origin register
- US FDA, United States
- Storage
- Store at room temperature, between 68°F to 77°F (20°C to 25°C). Keep in original container and protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 12 September 2019
- Identifiers
- RxCUI 2199679, 2199685DailyMed set ID 2102da5f-a1a0-4ac7-a1f6-38698cf7273aNDC 73154-050Application NDA211801
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
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 12 September 2019 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
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
Other strengths and forms of Tenapanor
Clinical summary
Tenapanor is a sodium-hydrogen exchanger 3 inhibitor indicated for treatment of irritable bowel syndrome with constipation (IBS-C) in adults. It is available as tablets for oral use. MedsAcross supplies Tenapanor 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 TenapanorFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- IBSRELA prescribing information (Ardelyx) · U.S. National Library of Medicine, DailyMed
Need Ibsrela 53.2 mg tablet 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.