FDA.reportPublic FDA data

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

RxCUI
2264606
RxNorm name
6 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe
Display name
6 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe
Full name
6 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)Rx2026-09-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

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 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
a8708417-2f74-4dfa-b6f9-ef88f902e0fcfibrin sealant (thrombin 500 UNT/mL, human) topical solution 6 mL Prefilled Syringe, frozen [PSN] · 6 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe [SCD] · fibrin sealant (thrombin 500 UNT/ML, human) topical solution 6 ML Prefilled Syringe, frozen [SY]314These 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 6 mL Prefilled Syringe, frozen [PSN] · 6 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe [SCD] · fibrin sealant (thrombin 500 UNT/ML, human) topical solution 6 ML Prefilled Syringe, frozen [SY]32These 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