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)Rx2026-09-01

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
51f19873-a63f-4229-9477-5da4ecf31cdeAFSTYLA 1 UNT Injection [PSN] · lonoctocog alfa 1 UNT Injection [Afstyla] [SBD] · Afstyla 1 UNT Injection [SY]313These 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