FDA.reportPublic FDA data

coagulation factor XIII a-subunit (recombinant) 1 UNT Injection

RxCUI
1488302
RxNorm name
coagulation factor XIII a-subunit (recombinant) 1 UNT Injection
Display name
coagulation factor XIII a-subunit (recombinant) 1 UNT Injection
Full name
coagulation factor XIII a-subunit (recombinant) 1 UNT Injection
Term type
PSN
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
125398TrettenCoagulation Factor XIII A-Subunit (Recombinant)351(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
8664978e-1814-4930-aca5-97a24455f6dfcoagulation factor XIII a-subunit (recombinant) 1 UNT Injection [PSN] · coagulation factor XIII a-subunit (recombinant) 1 UNT Injection [SCD]28These highlights do not include all the information needed to use TRETTEN safely and effectively. See full prescribing information for TRETTEN. TRETTEN, Coagulation Factor XIII A-Subunit (Recombinant) For Intravenous Use. Lyophilized Powder for Solution for Injection Initial U.S. Approval: 201320200630