NDC 61938-456

Infasurf 35.7 mg per 1 mL suspension

On the label: ONY Biotech Inc..

United States: 2

Where it's made

FactoryWhereRoleLast FDA inspection
ONY Biotech Inc.Amherst, NY, United StatesMakes it, makes the active ingredient, tests it and sterilizes it Serious problems, FDA actionFeb 5, 2026 · 9 inspections, 2 with FDA action
ONY Biotech Inc.Madera, CA, United StatesMakes the active ingredient Not inspected on record
ONY Biotech Inc.Amherst, NY, United StatesPackages it and labels it Serious problems, FDA actionFeb 5, 2026 · 9 inspections, 2 with FDA action

Product details

Generic drug
Calfactant: every company that makes it
Form
suspension, endotracheal
Strength
35.7 mg per 1 mL
Approval
BLA BLA020521
On the market since
Oct 18, 1999
Package NDCs
61938-456-03 61938-456-06
Official label
DailyMed (National Library of Medicine), updated Oct 29, 2026

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