FDA.reportPublic FDA data

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

RxCUI
2003666
RxNorm name
fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Prefilled Syringe [Tisseel]
Display name
fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Prefilled Syringe [Tisseel]
Full name
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)Rx2026-08-01

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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
b3f69e25-1b87-4507-81fa-582ea084673dfibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Prefilled Syringe [Tisseel] [SBD] · Tisseel (frozen) fibrin sealant (human) topical solution Prefilled Syringe [SY]29These 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