FDA.reportPublic FDA data

Xyntha 1 UNT Injection

RxCUI
1718996
RxNorm name
Xyntha 1 UNT Injection
Display name
Xyntha 1 UNT Injection
Full name
Xyntha 1 UNT Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:58

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125264Xyntha, Xyntha SolofuseAntihemophilic Factor (Recombinant), Plasma/Albumin Free351(a)Rx2026-06-01

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.

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
52e97c7f-8240-4cd6-afd2-c452ab2f6e32Xyntha 1 UNT InjectionPSN33These highlights do not include all the information needed to use XYNTHA safely and effectively. See full prescribing information for XYNTHA. XYNTHA ® (antihemophilic factor [recombinant]) lyophilized powder for solution, for intravenous injection Initial U.S. Approval: 200820250227
52e97c7f-8240-4cd6-afd2-c452ab2f6e32Xyntha 1 UNT InjectionSY33These highlights do not include all the information needed to use XYNTHA safely and effectively. See full prescribing information for XYNTHA. XYNTHA ® (antihemophilic factor [recombinant]) lyophilized powder for solution, for intravenous injection Initial U.S. Approval: 200820250227
52e97c7f-8240-4cd6-afd2-c452ab2f6e32antihemophilic factor, human recombinant residues 743-1636 deleted 1 UNT Injection [Xyntha]SBD33These highlights do not include all the information needed to use XYNTHA safely and effectively. See full prescribing information for XYNTHA. XYNTHA ® (antihemophilic factor [recombinant]) lyophilized powder for solution, for intravenous injection Initial U.S. Approval: 200820250227