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)Rx2026-08-01

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#

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
f5070a92-96b8-476a-a2dc-18b22d95e5e0RIXUBIS 1 UNT Injection [PSN] · nonacog alfa 1 UNT Injection [Rixubis] [SBD] · Rixubis (coagulation factor IX (recombinant human)) 1 UNT Injection [SY]314These 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