Donor Human Stool
Donor Human Stool is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Rebyota. Available dosage form: suspension.
Drug Details
- Generic Name
- Donor Human Stool
- Brand Names
- Rebyota
- Application Number
- BLA125739
- Sponsor
- Ferring Pharmaceuticals Inc.
- NDC Codes
- 1
- Dosage Forms
- SUSPENSION
- Routes
- RECTAL
- Active Ingredients
- DONOR HUMAN STOOL
Indications and Usage
1 INDICATIONS AND USAGE REBYOTA is 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. REBYOTA is 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. ( 1 ) Limitation of Use: REBYOTA is not indicated for treatment of CDI. Limitation of Use: REBYOTA is not indicated for treatment of CDI.