FDA.reportPublic FDA data

10 ML fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Prefilled Syringe [Tisseel]

RxCUI
2003670
RxNorm name
10 ML fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Prefilled Syringe [Tisseel]
Display name
10 ML fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Prefilled Syringe [Tisseel]
Full name
10 ML fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Prefilled Syringe [Tisseel]
Term type
SBD
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)Rx2026-06-01

RxNav Current And Historical NDCs#

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UNII Substances#

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DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
b3f69e25-1b87-4507-81fa-582ea084673d10 ML fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Prefilled Syringe [Tisseel]SBD9These 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
b3f69e25-1b87-4507-81fa-582ea084673dTISSEEL (frozen) fibrin sealant (human) topical solution 10 mL Prefilled SyringePSN9These 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
b3f69e25-1b87-4507-81fa-582ea084673dTisseel (frozen) fibrin sealant (human) topical solution 10 ML Prefilled SyringeSY9These 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