FDA.reportPublic FDA data

nonacog alfa 1 UNT Injection [BeneFIX]

RxCUI
1666317
RxNorm name
nonacog alfa 1 UNT Injection [BeneFIX]
Display name
nonacog alfa 1 UNT Injection [BeneFIX]
Full name
nonacog alfa 1 UNT Injection [BeneFIX]
Term type
SBD
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
103677BenefixCoagulation Factor IX (Recombinant)351(a)Rx2026-09-01

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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
85faa5bc-cee5-4ef1-8d80-bdbcb7eba1e4BeneFIX 1 UNT Injection [PSN] · nonacog alfa 1 UNT Injection [BeneFIX] [SBD] · BeneFIX (coagulation factor IX (recombinant human)) 1 UNT Injection [SY]345These 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