FDA.reportPublic FDA data

antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl 1 UNT Injection

RxCUI
2631088
RxNorm name
antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl 1 UNT Injection
Display name
antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl 1 UNT Injection
Full name
antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl 1 UNT Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:45

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125771ALTUVIIIOantihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl351(a)Rx2026-07-01

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALTUVIIIOANTIHEMOPHILIC FACTOR (RECOMBINANT), FC-VWF-XTEN FUSION PROTEIN-EHTLBioverativ Therapeutics Inc.01411972-df40-4ccf-88f0-d3220e5abda92026-02-23Warnings, Adverse reactionsExact identifier
rxcui: 2631088

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
01411972-df40-4ccf-88f0-d3220e5abda9antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl 1 UNT Injection [PSN] · antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl 1 UNT Injection [SCD] · antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl 1 UNT Injection [SY]310These highlights do not include all the information needed to use ALTUVIIIO ® safely and effectively. See full prescribing information for ALTUVIIIO. ALTUVIIIO [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl], lyophilized powder for solution, for intravenous use Initial U.S. Approval: 202320260223