FDA.reportPublic FDA data

prothrombin complex concentrate, human-lans 1 UNT Injection

RxCUI
2643204
RxNorm name
prothrombin complex concentrate, human-lans 1 UNT Injection
Display name
prothrombin complex concentrate, human-lans 1 UNT Injection
Full name
prothrombin complex concentrate, human-lans 1 UNT Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:02

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125776BalfaxarProthrombin complex concentrate, human-lans351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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No records found.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 IDRxNorm mappingsTermsSPL versionLabelEffective
68fa4f90-8b01-6498-4140-e0be5247c3feprothrombin complex concentrate, human-lans 1 UNT Injection [PSN] · coagulation factor IX, human-lans 1 UNT / coagulation factor X, human-lans 1 UNT / factor VII, human-lans 1 UNT / protein C, human-lans 1 UNT / protein S, human-lans 1 UNT / prothrombin, human-lans 1 UNT Injection [SCD] · prothrombin complex concentrate, human-lans 1 UNT Injection [SY]34These highlights do not include all the information needed to use BALFAXAR safely and effectively. See full prescribing information for BALFAXAR. BALFAXAR (prothrombin complex concentrate, human-lans) lyophilized powder for solution, for intravenous use Initial U.S. Approval: 202320230721