FDA.reportPublic FDA data

fibrin sealant (thrombin 6.5 UNT/mL, human) topical solution 10 mL Prefilled Syringe, frozen

RxCUI
1305909
RxNorm name
fibrin sealant (thrombin 6.5 UNT/mL, human) topical solution 10 mL Prefilled Syringe, frozen
Display name
fibrin sealant (thrombin 6.5 UNT/mL, human) topical solution 10 mL Prefilled Syringe, frozen
Full name
fibrin sealant (thrombin 6.5 UNT/mL, human) topical solution 10 mL Prefilled Syringe, frozen
Term type
PSN
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)Rx2026-06-01

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.

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
92fc93e1-9695-4705-90c5-4452a80bb074fibrin sealant (thrombin 6.5 UNT/mL, human) topical solution 10 mL Prefilled Syringe, frozenPSN12These 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
92fc93e1-9695-4705-90c5-4452a80bb074fibrin sealant (thrombin 6.5 UNT/ML, human) topical solution 10 ML Prefilled Syringe, frozenSY12These 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
92fc93e1-9695-4705-90c5-4452a80bb07410 ML fibrinogen, human 106 MG/ML / thrombin, human 6.5 UNT/ML Prefilled SyringeSCD12These 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