Medicine
Rebyota 50000000000 CFU/150 mL rectal suspension
Rebyota 50000000000 CFU/150 mL rectal suspension is a prescription medicine containing Donor human stool for rectal use, marketed by Ferring 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store the REBYOTA carton in an ultracold freezer (-60°C to -90°C, -76°F to…
Key facts
- Active ingredient (INN)
- Donor human stool
- Brand
- Rebyota
- Strength
- 50000000000 CFU/150 mL
- Dosage form
- Rectal suspension
- Route
- Rectal
- Packs
- 1 carton
- Marketing authorisation holder
- Ferring Pharmaceuticals
- Manufacturer
- Ferring Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store the REBYOTA carton in an ultracold freezer (-60°C to -90°C, -76°F to -130°F). Alternatively, store in a refrigerator (2°C to 8°C, 36°F to 46°F) for up to 5 days (including thaw time). DO NOT store the administration set in the freezer. Store the administration set at 10°C to 34°C (50°F to 93°F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 9 January 2023
- Identifiers
- RxCUI 2626732, 2626737DailyMed set ID 7af8a7f6-a441-4dc6-a151-138a89166fbbNDC 55566-9800Application BLA125739
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 |
|---|---|---|---|
| 1 carton in 1 carton / 1 bag in 1 carton / 150 mL in 1 bag | 55566-9800-2 | Ferring Pharmaceuticals | 9 January 2023 |
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 |
| 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
Donor human stool is a prescription medicine indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibiotic treatment for recurrent CDI. Limitation of Use. MedsAcross supplies Donor human stool 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 Donor human stoolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Rebyota prescribing information (Ferring Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Rebyota 50000000000 CFU/150 mL rectal suspension 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.