FDA.reportPublic FDA data

factor VIII, human recombinant 1 UNT Injection

RxCUI
1719222
RxNorm name
factor VIII, human recombinant 1 UNT Injection
Display name
factor VIII, human recombinant 1 UNT Injection
Full name
factor VIII, human recombinant 1 UNT Injection
Term type
SY
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
125574KovaltryAntihemophilic Factor (Recombinant), Full Length351(a)Rx2026-09-01
103375Bioclate (Armour), RecombinateAntihemophilic Factor (Recombinant)351(a)Rx2026-09-01
125063AdvateAntihemophilic Factor (Recombinant), Plasma/Albumin Free Method351(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 · 4 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
d99348b1-edad-41de-aed9-903a6f9f279fantihemophilic factor, human recombinant 1 UNT Injection [PSN] · antihemophilic factor, human recombinant 1 UNT Injection [SCD] · factor VIII, human recombinant 1 UNT Injection [SY]321RECOMBINATE ® [Antihemophilic Factor (Recombinant)]20250403
89ba5048-469c-4f08-a173-81b0c6f3004dantihemophilic factor, human recombinant 1 UNT Injection [PSN] · antihemophilic factor, human recombinant 1 UNT Injection [SCD] · factor VIII, human recombinant 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
80fa03d2-cd4c-4155-9b57-1396c4fa42daantihemophilic factor, human recombinant 1 UNT Injection [PSN] · antihemophilic factor, human recombinant 1 UNT Injection [SCD] · factor VIII, human recombinant 1 UNT Injection [SY]313These highlights do not include all the information needed to use ADVATE ® safely and effectively. See full prescribing information for ADVATE. ADVATE [antihemophilic factor (recombinant)] lyophilized powder for reconstitution, for intravenous injection Initial U.S. Approval: 200320250403
d74e59ba-bfeb-4c48-9596-da44328561a9antihemophilic factor, human recombinant 1 UNT Injection [PSN] · antihemophilic factor, human recombinant 1 UNT Injection [SCD] · factor VIII, human recombinant 1 UNT Injection [SY]37RECOMBINATE [Antihemophilic Factor (Recombinant)]20100526