FDA.reportPublic FDA data

Humate-P (expressed as von Willebrand factor) 1 UNT Injection

RxCUI
1661352
RxNorm name
Humate-P (expressed as von Willebrand factor) 1 UNT Injection
Display name
Humate-P (expressed as von Willebrand factor) 1 UNT Injection
Full name
Humate-P (expressed as von Willebrand factor) 1 UNT Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:20

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103960Humate-PAntihemophilic Factor/von Willebrand Factor Complex (Human)351(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
c5f4b63b-8d8b-45b3-b530-2f1c32a1b852Humate-P (expressed as von Willebrand factor) 1 UNT Injection [PSN] · factor VIII, human 1 UNT / von Willebrand factor, human 1 UNT Injection [Humate-P] [SBD] · Humate-P (expressed as von Willebrand factor) 1 UNT Injection [SY]316These highlights do not include all the information needed to use HUMATE-P safely and effectively. See full prescribing information for HUMATE-P. HUMATE-P [Antihemophilic Factor/von Willebrand Factor Complex (Human)] Lyophilized Powder for Reconstitution for Intravenous Use Only. Initial U.S. Approval: 198620200817