FDA.reportPublic FDA data

antihemophilic factor, human 1 UNT Injection [Koate]

RxCUI
1718970
RxNorm name
antihemophilic factor, human 1 UNT Injection [Koate]
Display name
antihemophilic factor, human 1 UNT Injection [Koate]
Full name
antihemophilic factor, human 1 UNT Injection [Koate]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:52

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
101130Koate, Koate-DviAntihemophilic Factor (Human)351(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 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
2f77d685-e382-b2e7-2414-0d3a3448688aKoate-DVI 1 UNT Injection [PSN] · antihemophilic factor, human 1 UNT Injection [Koate] [SBD] · Koate 1 UNT Injection [SY]323These highlights do not include all the information needed to use KOĀTE ® safely and effectively. See full prescribing information for KOĀTE. KOĀTE ® , Antihemophilic Factor (Human) Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: 197420231212
865df1e2-b4d1-dbf5-2899-a9c02df4d122Koate-DVI 1 UNT Injection [PSN] · antihemophilic factor, human 1 UNT Injection [Koate] [SBD] · Koate 1 UNT Injection [SY]310These highlights do not include all the information needed to use KOĀTE ® safely and effectively. See full prescribing information for KOĀTE. KOĀTE ® , Antihemophilic Factor (Human) Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: 197420231213