Quick answers
- What is Calfactant used for?
- The FDA-approved label (Infasurf, ONY Biotech Inc., March 31, 2026) says: “INFASURF 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 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Calfactant have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Calfactant?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Calfactant been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Calfactant?
- 1 company lists prescription products of Calfactant in the FDA NDC Directory, including ONY Biotech Inc..
What Calfactant is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INFASURF 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 …
— FDA label: Infasurf, ONY Biotech Inc., effective March 31, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Suspension |
|---|---|
| Route | Endotracheal |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Infasurf |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- ONY Biotech Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA020521 INFASURF PRESERVATIVE FREE | Ony | July 1, 1998 | 18, latest August 23, 2024 2024: Labeling · 2015: Manufacturing (CMC) · 2015: Manufacturing (CMC) |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 259611, 994039 |
|---|---|
| SPL set ID of the quoted label | 315c128a-272d-4c57-bfbe-1a8b3402af08 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA020521 |
| Active ingredients (FDA) | CALFACTANT |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Infasurf, ONY Biotech Inc., effective March 31, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →