FDA.reportPublic FDA data

lonoctocog alfa 1 UNT Injection [Afstyla]

RxCUI
1796384
RxNorm name
lonoctocog alfa 1 UNT Injection [Afstyla]
Display name
lonoctocog alfa 1 UNT Injection [Afstyla]
Full name
lonoctocog alfa 1 UNT Injection [Afstyla]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:58

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125591AfstylaAntihemophilic Factor (Recombinant), Single Chain351(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.

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
51f19873-a63f-4229-9477-5da4ecf31cdelonoctocog alfa 1 UNT Injection [Afstyla]SBD13These highlights do not include all the information needed to use AFSTYLA safely and effectively. See full prescribing information for AFSTYLA. AFSTYLA ® [Antihemophilic Factor (Recombinant), Single Chain] Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: 201620230623
51f19873-a63f-4229-9477-5da4ecf31cdeAfstyla 1 UNT InjectionSY13These highlights do not include all the information needed to use AFSTYLA safely and effectively. See full prescribing information for AFSTYLA. AFSTYLA ® [Antihemophilic Factor (Recombinant), Single Chain] Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: 201620230623
51f19873-a63f-4229-9477-5da4ecf31cdeAFSTYLA 1 UNT InjectionPSN13These highlights do not include all the information needed to use AFSTYLA safely and effectively. See full prescribing information for AFSTYLA. AFSTYLA ® [Antihemophilic Factor (Recombinant), Single Chain] Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: 201620230623