Prescription medicine
Bezlotoxumab Brand names: Zinplava
Bezlotoxumab (Zinplava) is a prescription medicine with an FDA approval on record since 2016. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the bezlotoxumab FDA label on DailyMed (effective November 12, 2024, Merck Sharp & Dohme LLC); the BLA 761046 record on Drugs@FDA; every bezlotoxumab label on DailyMed.
Highlights of the record
FDA label of November 12, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageZINPLAVA™ is indicated to reduce recurrence of Clostridioides difficile infection (CDI) in adults and pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for CDI and are at a high risk for CDI recurrence.
Forms and strengths
- 25 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- October 21, 2016 Zinplava, Merck Sharp Dohme; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 349 through July 30, 2026
What is bezlotoxumab used for?
From the label: indications and usageZINPLAVA™ is indicated to reduce recurrence of Clostridioides difficile infection (CDI) in adults and pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for CDI and are at a high risk for CDI recurrence. ZINPLAVA is a human monoclonal antibody that binds to Clostridioides difficile toxin B, indicated to reduce recurrence of Clostridioides difficile infection (CDI) in adults and pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for CDI and are at a high risk for CDI recurrence. ( 1 ) Limitation of Use: ZINPLAVA is not indicated for the treatment of CDI. ZINPLAVA is not an antibacterial drug. […]
Source: FDA drug label (ZINPLAVA), Merck Sharp & Dohme LLC, effective November 12, 2024 (SPL set 8f479bfe-2bfa-4cc5-9aee-1357364480b0), via openFDA; the full label on DailyMed
Is there a generic for bezlotoxumab (Zinplava)?
No generic bezlotoxumab is approved (Drugs@FDA, October 8, 2026).
- 2016 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for bezlotoxumab?
The FDA Adverse Event Reporting System holds 349 reports that list bezlotoxumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 63 are coded as a death and 109 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Bezlotoxumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other