FDA.reportPublic FDA data

nonacog alfa 1 UNT Injection

RxCUI
1666311
RxNorm name
nonacog alfa 1 UNT Injection
Display name
nonacog alfa 1 UNT Injection
Full name
nonacog alfa 1 UNT Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:07

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125446RixubisCoagulation Factor IX (Recombinant)351(a)Rx2026-06-01
125426IxinityCoagulation Factor IX (Recombinant)351(a)Disc2026-06-01
103677BenefixCoagulation Factor IX (Recombinant)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.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IxinityCOAGULATION FACTOR IX (RECOMBINANT)Medexus Pharma, Inc.26bc221d-c9bc-4aba-92f3-6c21acaaf1942024-04-03Warnings, Adverse reactionsExact identifier
rxcui: 1666311

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
85faa5bc-cee5-4ef1-8d80-bdbcb7eba1e4nonacog alfa 1 UNT InjectionSCD45These highlights do not include all the information needed to use BeneFIX safely and effectively. See full prescribing information for BeneFIX. BeneFIX ® [coagulation factor IX (recombinant)] lyophilized powder for solution, for intravenous use Initial U.S. Approval: 199720250224
85faa5bc-cee5-4ef1-8d80-bdbcb7eba1e4coagulation factor IX (recombinant human) 1 UNT InjectionPSN45These highlights do not include all the information needed to use BeneFIX safely and effectively. See full prescribing information for BeneFIX. BeneFIX ® [coagulation factor IX (recombinant)] lyophilized powder for solution, for intravenous use Initial U.S. Approval: 199720250224
f5070a92-96b8-476a-a2dc-18b22d95e5e0coagulation factor IX (recombinant human) 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 InjectionSCD14These 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
9521898c-61aa-44ab-8ab8-84274ca19943coagulation factor IX (recombinant human) 1 UNT InjectionPSN10These highlights do not include all the information needed to use IXINITY® safely and effectively. See full prescribing information for IXINITY.. IXINITY [coagulation factor IX (recombinant)] Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: 201520210223
9521898c-61aa-44ab-8ab8-84274ca19943nonacog alfa 1 UNT InjectionSCD10These highlights do not include all the information needed to use IXINITY® safely and effectively. See full prescribing information for IXINITY.. IXINITY [coagulation factor IX (recombinant)] Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: 201520210223
26bc221d-c9bc-4aba-92f3-6c21acaaf194nonacog alfa 1 UNT InjectionSCD8These highlights do not include all the information needed to use IXINITY® safely and effectively. See full prescribing information for IXINITY. IXINITY [coagulation factor IX (recombinant)] Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: 201520240403
26bc221d-c9bc-4aba-92f3-6c21acaaf194coagulation factor IX (recombinant human) 1 UNT InjectionPSN8These highlights do not include all the information needed to use IXINITY® safely and effectively. See full prescribing information for IXINITY. IXINITY [coagulation factor IX (recombinant)] Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: 201520240403