FDA.reportPublic FDA data

Advate 1 UNT Injection

RxCUI
1719225
RxNorm name
Advate 1 UNT Injection
Display name
Advate 1 UNT Injection
Full name
Advate 1 UNT Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:06

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125063AdvateAntihemophilic Factor (Recombinant), Plasma/Albumin Free Method351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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

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
80fa03d2-cd4c-4155-9b57-1396c4fa42daAdvate 1 UNT Injection [PSN] · antihemophilic factor, human recombinant 1 UNT Injection [Advate] [SBD] · Advate 1 UNT Injection [SY]313These highlights do not include all the information needed to use ADVATE ® safely and effectively. See full prescribing information for ADVATE. ADVATE [antihemophilic factor (recombinant)] lyophilized powder for reconstitution, for intravenous injection Initial U.S. Approval: 200320250403