calfactant · CALFACTANT 35.7 mg/mL · Suspension · Endotracheal · ONY Biotech Inc.
NDC 61938-0456-03 · 1 VIAL, GLASS in 1 CARTON / 3 mL in 1 VIAL, GLASS · BLA · View full market →
Only one company currently supplies this market — there is no backup if it stumbles. One of its named manufacturing plants, ONY Biotech Inc., failed FDA inspectionwithin the last two years — the agency’s most serious outcome.
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No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Not scored — fragility is computed for NADAC-priced NDCs.
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
There's no legal definition — it meets 1 of 6 public criteria. Why that matters →
No FDA shortage reports for this drug or its presentations.
No enforcement reports list this package NDC.
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| ONY Biotech Inc. | CALFACTANT 35.7 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
DrugDashboards, "Infasurf — NDC 61938-0456-03," retrieved September 3, 2026, https://drugdashboards.com/drug/61938045603.
Free to cite with attribution — see how the data is put together.