FDA.reportPublic FDA data

coagulation factor IX recombinant immunoglobulin G1 fusion protein 1 UNT Injection

RxCUI
1666320
RxNorm name
coagulation factor IX recombinant immunoglobulin G1 fusion protein 1 UNT Injection
Display name
coagulation factor IX recombinant immunoglobulin G1 fusion protein 1 UNT Injection
Full name
coagulation factor IX recombinant immunoglobulin G1 fusion protein 1 UNT Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:52

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125444AlprolixCoagulation Factor IX (Recombinant), Fc Fusion Protein351(a)Rx2026-07-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

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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
2fb3fb92-379d-4683-80d6-b06c0a7dc063coagulation factor ix (recombinant), fc fusion protein 1 UNT Injection [PSN] · coagulation factor IX recombinant immunoglobulin G1 fusion protein 1 UNT Injection [SCD]212These highlights do not include all the information needed to use ALPROLIX ® safely and effectively. See full prescribing information for ALPROLIX. ALPROLIX ® [coagulation factor IX (recombinant), Fc fusion protein], lyophilized powder for solution for intravenous injection. Initial U.S. Approval: 201420240516