FDA.reportPublic FDA data

fibrin sealant (thrombin 625 UNT/mL, human) topical solution 4 mL Prefilled Syringe, frozen

RxCUI
2003667
RxNorm name
fibrin sealant (thrombin 625 UNT/mL, human) topical solution 4 mL Prefilled Syringe, frozen
Display name
fibrin sealant (thrombin 625 UNT/mL, human) topical solution 4 mL Prefilled Syringe, frozen
Full name
fibrin sealant (thrombin 625 UNT/mL, human) topical solution 4 mL Prefilled Syringe, frozen
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:17

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103980TisseelFibrin Sealant (Tisseel)351(a)Rx2026-08-01

RxNav Current And Historical NDCs#

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UNII Substances#

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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
b3f69e25-1b87-4507-81fa-582ea084673dfibrin sealant (thrombin 625 UNT/mL, human) topical solution 4 mL Prefilled Syringe, frozen [PSN] · 4 ML fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Prefilled Syringe [SCD] · fibrin sealant (thrombin 625 UNT/ML, human) topical solution 4 ML Prefilled Syringe, frozen [SY]39These highlights do not include all the information needed to use TISSEEL safely and effectively. See full prescribing information for TISSEEL. TISSEEL [Fibrin Sealant] Frozen solution and lyophilized powder for solution for topical use only Initial U.S. Approval: 199820250930