FDA.reportPublic FDA data

Rixubis (coagulation factor IX (recombinant human)) 1 UNT Injection

RxCUI
1666314
RxNorm name
Rixubis (coagulation factor IX (recombinant human)) 1 UNT Injection
Display name
Rixubis (coagulation factor IX (recombinant human)) 1 UNT Injection
Full name
Rixubis (coagulation factor IX (recombinant human)) 1 UNT Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:28

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125446RixubisCoagulation Factor IX (Recombinant)351(a)Rx2026-06-01

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.

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
f5070a92-96b8-476a-a2dc-18b22d95e5e0Rixubis (coagulation factor IX (recombinant human)) 1 UNT InjectionSY14These highlights do not include all the information needed to use RIXUBIS ® safely and effectively. See full prescribing information for RIXUBIS. RIXUBIS [Coagulation Factor IX (Recombinant)] For Intravenous Injection, Lyophilized Powder for Solution Initial U.S. Approval: 201320260512
f5070a92-96b8-476a-a2dc-18b22d95e5e0RIXUBIS 1 UNT InjectionPSN14These highlights do not include all the information needed to use RIXUBIS ® safely and effectively. See full prescribing information for RIXUBIS. RIXUBIS [Coagulation Factor IX (Recombinant)] For Intravenous Injection, Lyophilized Powder for Solution Initial U.S. Approval: 201320260512
f5070a92-96b8-476a-a2dc-18b22d95e5e0nonacog alfa 1 UNT Injection [Rixubis]SBD14These highlights do not include all the information needed to use RIXUBIS ® safely and effectively. See full prescribing information for RIXUBIS. RIXUBIS [Coagulation Factor IX (Recombinant)] For Intravenous Injection, Lyophilized Powder for Solution Initial U.S. Approval: 201320260512