FDA.reportPublic FDA data

2 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe [Vistaseal]

RxCUI
2264371
RxNorm name
2 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe [Vistaseal]
Display name
2 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe [Vistaseal]
Full name
2 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe [Vistaseal]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:14

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125640VistasealFibrin Sealant (Human)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
a8708417-2f74-4dfa-b6f9-ef88f902e0fc2 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe [Vistaseal]SBD14These highlights do not include all the information needed to use VISTASEAL™ safely and effectively. See full prescribing information for VISTASEAL. VISTASEAL™ [Fibrin Sealant (Human)] Frozen solutions of fibrinogen and thrombin For Topical Use Only Initial U.S. Approval: 201720250813
a8708417-2f74-4dfa-b6f9-ef88f902e0fcVistaSeal (Frozen) fibrin sealant (human) topical solution 2 mL Prefilled SyringePSN14These highlights do not include all the information needed to use VISTASEAL™ safely and effectively. See full prescribing information for VISTASEAL. VISTASEAL™ [Fibrin Sealant (Human)] Frozen solutions of fibrinogen and thrombin For Topical Use Only Initial U.S. Approval: 201720250813
a8708417-2f74-4dfa-b6f9-ef88f902e0fcVistaSeal (Frozen) fibrin sealant (human) topical solution 2 ML Prefilled SyringeSY14These highlights do not include all the information needed to use VISTASEAL™ safely and effectively. See full prescribing information for VISTASEAL. VISTASEAL™ [Fibrin Sealant (Human)] Frozen solutions of fibrinogen and thrombin For Topical Use Only Initial U.S. Approval: 201720250813
e832dbe8-ff52-4656-a61d-3140731aa1232 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe [Vistaseal]SBD2These highlights do not include all the information needed to use VISTASEAL™ safely and effectively. See full prescribing information for VISTASEAL. VISTASEAL™ [Fibrin Sealant (Human)] Frozen solutions of fibrinogen and thrombin For Topical Use Only Initial U.S. Approval: 201720241216
e832dbe8-ff52-4656-a61d-3140731aa123VistaSeal (Frozen) fibrin sealant (human) topical solution 2 ML Prefilled SyringeSY2These highlights do not include all the information needed to use VISTASEAL™ safely and effectively. See full prescribing information for VISTASEAL. VISTASEAL™ [Fibrin Sealant (Human)] Frozen solutions of fibrinogen and thrombin For Topical Use Only Initial U.S. Approval: 201720241216
e832dbe8-ff52-4656-a61d-3140731aa123VistaSeal (Frozen) fibrin sealant (human) topical solution 2 mL Prefilled SyringePSN2These highlights do not include all the information needed to use VISTASEAL™ safely and effectively. See full prescribing information for VISTASEAL. VISTASEAL™ [Fibrin Sealant (Human)] Frozen solutions of fibrinogen and thrombin For Topical Use Only Initial U.S. Approval: 201720241216