calfactant 35 MG/ML Intratracheal Suspension

RxCUI: 259611
RxNorm name: calfactant 35 MG/ML Intratracheal Suspension
Display name: calfactant 35 MG/ML Intratracheal Suspension
Full name: calfactant 35 MG/ML Intratracheal Suspension
Term type: SCD
Status: DailyMed mapping
Updated: 2026-06-04 23:38:52

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
020521	Infasurf	calfactant	351(a)	Rx	2026-08-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
INFASURF	CALFACTANT	ONY Biotech Inc.	315c128a-272d-4c57-bfbe-1a8b3402af08	2026-03-31	Warnings, Adverse reactions	Exact identifier rxcui: 259611

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set ID	RxNorm mappings	Terms	SPL version	Label	Effective
315c128a-272d-4c57-bfbe-1a8b3402af08	calfactant 35 MG/ML Intratracheal Suspension [PSN] · calfactant 35 MG/ML Intratracheal Suspension [SCD]	2	14	These 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: 1998	20260331