FDA.reportPublic FDA data

TISSEEL

Product NDC
0338-8402
Requested package NDC
0338-8402-10
11-digit product format
003388402
Labeler code
0338
Product ID
0338-8402_92e85779-aead-491b-bbd5-e17bbb517580
Type
PLASMA DERIVATIVE
Nonproprietary name
fibrinogen human, human thrombin
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Baxter Healthcare Corporation
Application
BLA103980
Marketing category
BLA
Marketing start
1998-05-01
Marketing end
0000-00-00
Substance
FIBRINOGEN HUMAN; HUMAN THROMBIN
Active strength
90 mg/mL; [iU]/mL
Pharmacologic classes
Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Factor Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0338-84020338-8402-10DDiscontinued by firm2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0338-84020338-8402-10DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
0338-8402-01TISSEELFibrin Sealant2 mL in 1 SYRINGE, PLASTICSOLUTION29
0338-8402-02TISSEELFibrin Sealant1 in 1 CARTONSOLUTION19
0338-8402-03TISSEELFibrin Sealant4 mL in 1 SYRINGE, PLASTICSOLUTION49
0338-8402-04TISSEELFibrin Sealant1 in 1 CARTONSOLUTION19
0338-8402-09TISSEELFibrin Sealant10 mL in 1 SYRINGE, PLASTICSOLUTION109
0338-8402-10TISSEELFibrin Sealant1 in 1 CARTONSOLUTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-8402-01ML - Milliliter0338-8402cbf2520f-e91d-44fa-a468-64bd4e21cbe312022-06-06
0338-8402-02ML - Milliliter0338-840295155609-93b5-4cc5-9907-8c99429aef2812018-01-12
0338-8402-03ML - Milliliter0338-840253cca17c-cdbe-42fb-a3c0-cd18878c3fbe12022-06-06
0338-8402-04ML - Milliliter0338-840218b1ebf7-b9ce-41a9-8593-0bdaefd9efd912018-01-12
0338-8402-09ML - Milliliter0338-8402b6027cf3-c779-4169-8fce-e438b0ba32e612022-06-06
0338-8402-10ML - Milliliter0338-8402ab4c2acb-d2d6-406f-bd13-b1e43ce263ca12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-8402TISSEEL FIBRIN SEALANT (FIBRINOGEN HUMAN, HUMAN THROMBIN) KIT TISSEEL FIBRIN SEALANT (FIBRINOGEN HUMAN, HUMAN THROMBIN) SOLUTION [BAXTER HEALTHCARE CORPORATION]8Legacy NDC, 6 package rows20240802_b3f69e25-1b87-4507-81fa-582ea084673d.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103980TisseelFibrin Sealant (Tisseel)351(a)Rx2026-08-01

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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0338-8402-10003388402101 SYRINGE, PLASTIC in 1 CARTON (0338-8402-10) > 10 mL in 1 SYRINGE, PLASTIC (0338-8402-09) 1998-05-010000-00-00NoNoCurrent