Medicine
Mytesi 125 mg tablet
Mytesi 125 mg tablet is a prescription medicine containing Crofelemer for oral use, marketed by Napo 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-25°C (68°F-77°F), excursions permitted between 15°C-30°C…
Key facts
- Active ingredient (INN)
- Crofelemer
- Brand
- Mytesi
- Strength
- 125 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 60 tablets
- Marketing authorisation holder
- Napo Pharmaceuticals
- Manufacturer
- Napo Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C-25°C (68°F-77°F), excursions permitted between 15°C-30°C (59°F-86°F). See USP Controlled Room Temperature.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A07XA06 Crofelemer
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 August 2016
- Identifiers
- RxCUI 1364454, 1806878DailyMed set ID 45584fba-8081-4cd1-a21e-3ea8237f62ffNDC 70564-802Application NDA202292
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 |
|---|---|---|---|
| 60 tablet, coated in 1 bottle | 70564-802-60 | Napo Pharmaceuticals | 1 August 2016 |
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 31 December 2012 | 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
Clinical summary
Crofelemer is an antidiarrheal indicated for symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy. It is available as tablets for oral use. MedsAcross supplies Crofelemer 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 CrofelemerFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- MYTESI prescribing information (Napo Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Mytesi 125 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.