FDA.reportPublic FDA data

Artiss (Frozen) fibrin sealant (human) topical solution 2 ML Prefilled Syringe

RxCUI
1305892
RxNorm name
Artiss (Frozen) fibrin sealant (human) topical solution 2 ML Prefilled Syringe
Display name
Artiss (Frozen) fibrin sealant (human) topical solution 2 ML Prefilled Syringe
Full name
Artiss (Frozen) fibrin sealant (human) topical solution 2 ML Prefilled Syringe
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:08

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125266ArtissFibrin Sealant (Human)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
92fc93e1-9695-4705-90c5-4452a80bb074ARTISS (Frozen) fibrin sealant (human) topical solution 2 mL Prefilled Syringe [PSN] · 2 ML fibrinogen, human 106 MG/ML / thrombin, human 6.5 UNT/ML Prefilled Syringe [Artiss] [SBD] · Artiss (Frozen) fibrin sealant (human) topical solution 2 ML Prefilled Syringe [SY]312These highlights do not include all the information needed to use ARTISS safely and effectively. See full prescribing information for ARTISS. ARTISS [Fibrin Sealant (Human)] Frozen Solution for topical application Initial U.S. Approval: 200820250930