FDA.reportPublic FDA data

Novoeight 1 UNT Injection

RxCUI
1719246
RxNorm name
Novoeight 1 UNT Injection
Display name
Novoeight 1 UNT Injection
Full name
Novoeight 1 UNT Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:46

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125466NovoeightAntihemophilic Factor (Recombinant)351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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

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
0a19a631-f494-48ac-8cab-7d572bf7b03dNovoeight 1 UNT Injection [PSN] · turoctocog alfa 1 UNT Injection [Novoeight] [SBD] · Novoeight 1 UNT Injection [SY]312These highlights do not include all the information needed to use NOVOEIGHT safely and effectively. See full prescribing information for NOVOEIGHT. NOVOEIGHT (antihemophilic factor, recombinant) lyophilized powder for solution, for intravenous use Initial U.S. Approval: 201320200731