FDA.reportPublic FDA data

Xyntha 1 UNT Prefilled Syringe

RxCUI
1720166
RxNorm name
Xyntha 1 UNT Prefilled Syringe
Display name
Xyntha 1 UNT Prefilled Syringe
Full name
Xyntha 1 UNT Prefilled Syringe
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:50

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125264Xyntha, Xyntha SolofuseAntihemophilic Factor (Recombinant), Plasma/Albumin Free351(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
25ea1c3c-14a2-ef11-302e-012bd683924fXyntha 1 UNT Prefilled Syringe [PSN] · antihemophilic factor, human recombinant residues 743-1636 deleted 1 UNT Prefilled Syringe [Xyntha] [SBD] · Xyntha 1 UNT Prefilled Syringe [SY]335These highlights do not include all the information needed to use XYNTHA safely and effectively. See full prescribing information for XYNTHA. XYNTHA ® SOLOFUSE ® (antihemophilic factor [recombinant]) lyophilized powder for solution in prefilled dual-chamber syringe, for intravenous injection Initial U.S. Approval: 200820260316