FDA.reportPublic FDA data

calfactant 35 MG/ML Intratracheal Suspension [Infasurf]

RxCUI
994039
RxNorm name
calfactant 35 MG/ML Intratracheal Suspension [Infasurf]
Display name
calfactant 35 MG/ML Intratracheal Suspension [Infasurf]
Full name
calfactant 35 MG/ML Intratracheal Suspension [Infasurf]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:52

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020521Infasurfcalfactant351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
315c128a-272d-4c57-bfbe-1a8b3402af08calfactant 35 MG/ML Intratracheal Suspension [Infasurf]SBD14These highlights do not include all the information needed to use INFASURF ® safely and effectively. See full prescribing information for INFASURF. INFASURF ® (calfactant) intratracheal suspension Initial U.S. Approval: 199820260331
315c128a-272d-4c57-bfbe-1a8b3402af08INFASURF 35 MG/mL Intratracheal SuspensionPSN14These highlights do not include all the information needed to use INFASURF ® safely and effectively. See full prescribing information for INFASURF. INFASURF ® (calfactant) intratracheal suspension Initial U.S. Approval: 199820260331
315c128a-272d-4c57-bfbe-1a8b3402af08Infasurf 35 MG/ML Intratracheal SuspensionSY14These highlights do not include all the information needed to use INFASURF ® safely and effectively. See full prescribing information for INFASURF. INFASURF ® (calfactant) intratracheal suspension Initial U.S. Approval: 199820260331