FDA.reportPublic FDA data

4 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe

RxCUI
2264603
RxNorm name
4 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe
Display name
4 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe
Full name
4 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe
Term type
SCD
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-ef88f902e0fc4 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled SyringeSCD14These 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-ef88f902e0fcfibrin sealant (thrombin 500 UNT/mL, human) topical solution 4 mL Prefilled Syringe, frozenPSN14These 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-ef88f902e0fcfibrin sealant (thrombin 500 UNT/ML, human) topical solution 4 ML Prefilled Syringe, frozenSY14These 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-3140731aa123fibrin sealant (thrombin 500 UNT/ML, human) topical solution 4 ML Prefilled Syringe, frozenSY2These 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-3140731aa123fibrin sealant (thrombin 500 UNT/mL, human) topical solution 4 mL Prefilled Syringe, frozenPSN2These 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-3140731aa1234 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled SyringeSCD2These 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