FDA.reportPublic FDA data

simoctocog alfa 1 UNT Injection [Nuwiq]

RxCUI
1729091
RxNorm name
simoctocog alfa 1 UNT Injection [Nuwiq]
Display name
simoctocog alfa 1 UNT Injection [Nuwiq]
Full name
simoctocog alfa 1 UNT Injection [Nuwiq]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:23

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125555NuwiqAntihemophilic Factor (Recombinant)351(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
d6cb51f8-3acd-412c-93ec-41a8017dff3eNUWIQ 1 UNT Injection [PSN] · simoctocog alfa 1 UNT Injection [Nuwiq] [SBD] · Nuwiq 1 UNT Injection [SY]316These highlights do not include all the information needed to use NUWIQ safely and effectively. See full prescribing information for NUWIQ. NUWIQ®, Antihemophilic Factor (Recombinant) Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: 201520241226