FDA.reportPublic FDA data

coagulation factor IX (recombinant human), albumin fusion protein 1 UNT Injection

RxCUI
1743994
RxNorm name
coagulation factor IX (recombinant human), albumin fusion protein 1 UNT Injection
Display name
coagulation factor IX (recombinant human), albumin fusion protein 1 UNT Injection
Full name
coagulation factor IX (recombinant human), albumin fusion protein 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
125582IdelvionCoagulation Factor IX (Recombinant), Albumin Fusion Protein351(a)Rx2026-07-01

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
f74301bf-95e2-44ab-a8b6-98aa07b04683albutrepenonacog alfa 1 UNT Injection [PSN] · albutrepenonacog alfa 1 UNT Injection [SCD] · coagulation factor IX (recombinant human), albumin fusion protein 1 UNT Injection [SY]312These highlights do not include all the information needed to use IDELVION ® safely and effectively. See full prescribing information for IDELVION. IDELVION [Coagulation Factor IX (Recombinant), Albumin Fusion Protein] Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: 201620230630