FDA.reportPublic FDA data

antihemophilic factor, human 1 UNT Injection

RxCUI
1718962
RxNorm name
antihemophilic factor, human 1 UNT Injection
Display name
antihemophilic factor, human 1 UNT Injection
Full name
antihemophilic factor, human 1 UNT Injection
Term type
SCD
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)Rx2026-06-01
101448Hemofil MAntihemophilic Factor (Human)351(a)Rx2026-06-01

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.

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
2f77d685-e382-b2e7-2414-0d3a3448688aantihemophilic factor, human 1 UNT InjectionSCD23These 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
2f77d685-e382-b2e7-2414-0d3a3448688afactor VIII, human 1 UNT InjectionSY23These 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
2f77d685-e382-b2e7-2414-0d3a3448688aantihemophilic factor, human 1 UNT InjectionPSN23These 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
b8953ff7-3bba-4a0b-a486-f26fb81f05d9antihemophilic factor, human 1 UNT InjectionPSN1520250306
b8953ff7-3bba-4a0b-a486-f26fb81f05d9factor VIII, human 1 UNT InjectionSY1520250306
b8953ff7-3bba-4a0b-a486-f26fb81f05d9antihemophilic factor, human 1 UNT InjectionSCD1520250306
865df1e2-b4d1-dbf5-2899-a9c02df4d122antihemophilic factor, human 1 UNT InjectionPSN10These 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
865df1e2-b4d1-dbf5-2899-a9c02df4d122factor VIII, human 1 UNT InjectionSY10These 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
865df1e2-b4d1-dbf5-2899-a9c02df4d122antihemophilic factor, human 1 UNT InjectionSCD10These 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