FDA.reportPublic FDA data

TISSEEL

Product NDC
0338-4301
11-digit product format
003384301
Labeler code
0338
Product ID
0338-4301_e704d5a7-9db0-4f0f-8267-7ea92d8d882e
Type
PLASMA DERIVATIVE
Nonproprietary name
fibrinogen human, human thrombin
Dosage form
KIT
Labeler
Baxter Healthcare Corporation
Application
BLA103980
Marketing category
BLA
Marketing start
1998-05-01
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TISSEEL
Brand name suffix
Fibrin Sealant
Listing expiration
2026-12-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-4301-02TISSEELFibrin Sealant1 in 1 CARTONKIT19
0338-7112-01TISSEELFibrin Sealant1 mL in 1 VIAL, GLASSPOWDER, FOR SOLUTION1 mL86.5 mg in 1mL9
0338-7332-01TISSEELFibrin Sealant1 mL in 1 VIAL, GLASSPOWDER, FOR SOLUTION1 mL500 [iU] in 1mL9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-4301-02EA - Each0338-430191f1bfb1-cfd5-4036-b756-9157f586994812018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-4301TISSEEL FIBRIN SEALANT (FIBRINOGEN HUMAN, HUMAN THROMBIN) KIT TISSEEL FIBRIN SEALANT (FIBRINOGEN HUMAN, HUMAN THROMBIN) SOLUTION [BAXTER HEALTHCARE CORPORATION]8Current NDC, Legacy NDC, 3 package rows20240802_b3f69e25-1b87-4507-81fa-582ea084673d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2003660fibrin sealant (thrombin 625 UNT/ML, human) Topical SolutionPSNb3f69e25-1b87-4507-81fa-582ea084673d9
2003669fibrin sealant (thrombin 625 UNT/mL, human) topical solution 10 mL Prefilled Syringe, frozenPSNb3f69e25-1b87-4507-81fa-582ea084673d9
2003663fibrin sealant (thrombin 625 UNT/mL, human) topical solution 2 mL Prefilled Syringe, frozenPSNb3f69e25-1b87-4507-81fa-582ea084673d9
2003667fibrin sealant (thrombin 625 UNT/mL, human) topical solution 4 mL Prefilled Syringe, frozenPSNb3f69e25-1b87-4507-81fa-582ea084673d9
2003670TISSEEL (frozen) fibrin sealant (human) topical solution 10 mL Prefilled SyringePSNb3f69e25-1b87-4507-81fa-582ea084673d9
2003664TISSEEL (frozen) fibrin sealant (human) topical solution 2 mL Prefilled SyringePSNb3f69e25-1b87-4507-81fa-582ea084673d9
2003668TISSEEL (frozen) fibrin sealant (human) topical solution 4 mL Prefilled SyringePSNb3f69e25-1b87-4507-81fa-582ea084673d9
2003662TISSEEL, fibrin sealant (human) Topical SolutionPSNb3f69e25-1b87-4507-81fa-582ea084673d9
200367010 ML fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Prefilled Syringe [Tisseel]SBDb3f69e25-1b87-4507-81fa-582ea084673d9
20036642 ML fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Prefilled Syringe [Tisseel]SBDb3f69e25-1b87-4507-81fa-582ea084673d9
20036684 ML fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Prefilled Syringe [Tisseel]SBDb3f69e25-1b87-4507-81fa-582ea084673d9
2003666fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Prefilled Syringe [Tisseel]SBDb3f69e25-1b87-4507-81fa-582ea084673d9
2003662fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Topical Solution [Tisseel]SBDb3f69e25-1b87-4507-81fa-582ea084673d9
200366910 ML fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Prefilled SyringeSCDb3f69e25-1b87-4507-81fa-582ea084673d9
20036632 ML fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Prefilled SyringeSCDb3f69e25-1b87-4507-81fa-582ea084673d9
20036674 ML fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Prefilled SyringeSCDb3f69e25-1b87-4507-81fa-582ea084673d9
2003665fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Prefilled SyringeSCDb3f69e25-1b87-4507-81fa-582ea084673d9
2003660fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Topical SolutionSCDb3f69e25-1b87-4507-81fa-582ea084673d9
2003660fibrin sealant (thrombin 625 UNT/ML, human) Topical SolutionSYb3f69e25-1b87-4507-81fa-582ea084673d9
2003669fibrin sealant (thrombin 625 UNT/ML, human) topical solution 10 ML Prefilled Syringe, frozenSYb3f69e25-1b87-4507-81fa-582ea084673d9
2003663fibrin sealant (thrombin 625 UNT/ML, human) topical solution 2 ML Prefilled Syringe, frozenSYb3f69e25-1b87-4507-81fa-582ea084673d9
2003667fibrin sealant (thrombin 625 UNT/ML, human) topical solution 4 ML Prefilled Syringe, frozenSYb3f69e25-1b87-4507-81fa-582ea084673d9
2003670Tisseel (frozen) fibrin sealant (human) topical solution 10 ML Prefilled SyringeSYb3f69e25-1b87-4507-81fa-582ea084673d9
2003664Tisseel (frozen) fibrin sealant (human) topical solution 2 ML Prefilled SyringeSYb3f69e25-1b87-4507-81fa-582ea084673d9
2003668Tisseel (frozen) fibrin sealant (human) topical solution 4 ML Prefilled SyringeSYb3f69e25-1b87-4507-81fa-582ea084673d9
2003666Tisseel (frozen) fibrin sealant (human) topical solution Prefilled SyringeSYb3f69e25-1b87-4507-81fa-582ea084673d9
2003662TISSEEL, fibrin sealant (human) Topical SolutionSYb3f69e25-1b87-4507-81fa-582ea084673d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-4301-02003384301021 KIT in 1 CARTON (0338-4301-02) * 1 mL in 1 VIAL, GLASS (0338-7332-01) * 1 mL in 1 VIAL, GLASS (0338-7201-01) * 1 mL in 1 VIAL, GLASS (0338-7401-01) * 1 mL in 1 VIAL, GLASS (0338-7112-01) 1 kit1998-05-010000-00-00NoNoCurrent
0338-7112-01003387112011 mL in 1 VIAL, GLASS1 mlHistorical
0338-7332-01003387332011 mL in 1 VIAL, GLASS1 mlHistorical