Prescription medicine
Beractant Brand names: Survanta
Beractant (Survanta) is a prescription medicine with an FDA approval on record since 1991. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the beractant FDA label on DailyMed (effective October 15, 2020, AbbVie Inc.); the BLA 20032 record on Drugs@FDA; every beractant label on DailyMed.
Highlights of the record
FDA label of October 15, 2020; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageSURVANTA is indicated for prevention and treatment (“rescue”) of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants.
Forms and strengths
- 25 mg/ml
Suspension.
On the market
- Earliest approval on file
- July 1, 1991 Survanta, Abbvie; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- 367 through July 30, 2026
What is beractant used for?
From the label: indications and usageSURVANTA is indicated for prevention and treatment (“rescue”) of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants.
FDA pharmacologic class: Surfactant.
Source: FDA drug label (Survanta), AbbVie Inc., effective October 15, 2020 (SPL set 7ef9e3a5-fc39-4ae1-0dad-6b47a1684635), via openFDA; the full label on DailyMed
Is there a generic for beractant (Survanta)?
No generic beractant is approved (Drugs@FDA, October 8, 2026).
- 1991 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 beractant?
The FDA Adverse Event Reporting System holds 367 reports that list beractant among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 221 are coded as a death and 72 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
- Beractant side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other