FDA.reportPublic FDA data

Kovaltry 1 UNT Injection

RxCUI
1743374
RxNorm name
Kovaltry 1 UNT Injection
Display name
Kovaltry 1 UNT Injection
Full name
Kovaltry 1 UNT Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:07

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125574KovaltryAntihemophilic Factor (Recombinant), Full Length351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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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
89ba5048-469c-4f08-a173-81b0c6f3004dKovaltry 1 UNT Injection [PSN] · antihemophilic factor, human recombinant 1 UNT Injection [Kovaltry] [SBD] · Kovaltry 1 UNT Injection [SY]318These highlights do not include all the information needed to use KOVALTRY safely and effectively. See full prescribing information for KOVALTRY. KOVALTRY [Antihemophilic Factor (Recombinant)] Lyophilized Powder for Solution for Intravenous Injection – Reconstitution with Vial Adapter Initial U.S. Approval: 201620260302