FDA.reportPublic FDA data

nonacog alfa 1 UNT Injection [Ixinity]

RxCUI
1666328
RxNorm name
nonacog alfa 1 UNT Injection [Ixinity]
Display name
nonacog alfa 1 UNT Injection [Ixinity]
Full name
nonacog alfa 1 UNT Injection [Ixinity]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:09

Purple Book Biologic Products#

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

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: 1666328

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
9521898c-61aa-44ab-8ab8-84274ca19943nonacog alfa 1 UNT Injection [Ixinity]SBD10These 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-8ab8-84274ca19943IXINITY 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-8ab8-84274ca19943Ixinity (coagulation factor IX (recombinant human)) 1 UNT InjectionSY10These 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-92f3-6c21acaaf194IXINITY 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
26bc221d-c9bc-4aba-92f3-6c21acaaf194Ixinity (coagulation factor IX (recombinant human)) 1 UNT InjectionSY8These 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-92f3-6c21acaaf194nonacog alfa 1 UNT Injection [Ixinity]SBD8These 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