Prescription medicine
Calfactant Brand names: Infasurf
Calfactant (Infasurf) is a prescription medicine with an FDA approval on record since 1998. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the calfactant FDA label on DailyMed (effective March 31, 2026, ONY Biotech Inc.); the BLA 20521 record on Drugs@FDA; every calfactant label on DailyMed.
Highlights of the record
FDA label of March 31, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageINFASURF is indicated: to reduce the risk of respiratory distress syndrome (RDS) in preterm neonates <29 weeks of gestational age at risk for RDS.
Forms and strengths
- 35.7 mg/ml
Suspension.
On the market
- Earliest approval on file
- July 1, 1998 Infasurf Preservative Free, Ony; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- 63 through July 30, 2026
What is calfactant used for?
From the label: indications and usageINFASURF is indicated: to reduce the risk of respiratory distress syndrome (RDS) in preterm neonates <29 weeks of gestational age at risk for RDS. for the rescue treatment of RDS in preterm neonates ≤72 hours of age with RDS who require endotracheal intubation. INFASURF ® is a surfactant indicated: to reduce the risk of respiratory distress syndrome (RDS) in preterm neonates < 29 weeks gestational age at risk for RDS. (1) for the rescue treatment of preterm neonates ≤72 hours of age with RDS who require endotracheal intubation.
FDA pharmacologic class: Surfactant.
Source: FDA drug label (INFASURF), BLA020521 (Ony), as published by ONY Biotech Inc., effective March 31, 2026 (SPL set 315c128a-272d-4c57-bfbe-1a8b3402af08), via openFDA; the full label on DailyMed
Is there a generic for calfactant (Infasurf)?
No generic calfactant is approved (Drugs@FDA, October 8, 2026).
- 1998 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 calfactant?
The FDA Adverse Event Reporting System holds 63 reports that list calfactant among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 11 are coded as a death and 7 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?
- Other surfactants
- the pharmacologic class, with prices and generics
- Calfactant side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other