NDC 0944-8402

TISSEEL Frozen

Fibrinogen Human And Thrombin Human

TISSEEL Frozen is a Topical Solution in the Plasma Derivative category. It is labeled and distributed by Baxalta Us Inc.. The primary component is Fibrinogen Human; Human Thrombin.

Product ID0944-8402_3d62a922-847e-4810-9045-a83d3b967ea2
NDC0944-8402
Product TypePlasma Derivative
Proprietary NameTISSEEL Frozen
Generic NameFibrinogen Human And Thrombin Human
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2011-02-18
Marketing End Date2019-07-31
Marketing CategoryBLA / BLA
Application NumberBLA103980
Labeler NameBaxalta US Inc.
Substance NameFIBRINOGEN HUMAN; HUMAN THROMBIN
Active Ingredient Strength90 [iU]/mL; [iU]/mL
Pharm ClassesHuman Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [CS],Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [CS]
NDC Exclude FlagN

Packaging

NDC 0944-8402-10

1 SYRINGE, PLASTIC in 1 CARTON (0944-8402-10) > 10 mL in 1 SYRINGE, PLASTIC
Marketing Start Date2011-02-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0944-8402-10 [00944840210]

TISSEEL Frozen SOLUTION
Marketing CategoryBLA
Application NumberBLA103980
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date1998-05-01
Marketing End Date2019-07-31

NDC 0944-8402-09 [00944840209]

TISSEEL Frozen SOLUTION
Marketing CategoryBLA
Application NumberBLA103980
Product TypePLASMA DERIVATIVE
Marketing Start Date1998-05-01
Marketing End Date2019-07-31

NDC 0944-8402-03 [00944840203]

TISSEEL Frozen SOLUTION
Marketing CategoryBLA
Application NumberBLA103980
Product TypePLASMA DERIVATIVE
Marketing Start Date1998-05-01
Marketing End Date2019-07-31

NDC 0944-8402-02 [00944840202]

TISSEEL Frozen SOLUTION
Marketing CategoryBLA
Application NumberBLA103980
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date1998-05-01
Marketing End Date2019-07-31

NDC 0944-8402-01 [00944840201]

TISSEEL Frozen SOLUTION
Marketing CategoryBLA
Application NumberBLA103980
Product TypePLASMA DERIVATIVE
Marketing Start Date1998-05-01
Marketing End Date2019-07-31

NDC 0944-8402-04 [00944840204]

TISSEEL Frozen SOLUTION
Marketing CategoryBLA
Application NumberBLA103980
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date1998-05-01
Marketing End Date2019-07-31

Drug Details

Active Ingredients

IngredientStrength
FIBRINOGEN HUMAN90 [iU]/mL

Pharmacological Class

  • Human Blood Coagulation Factor [EPC]
  • Increased Coagulation Activity [PE]
  • Blood Coagulation Factors [CS]
  • Human Blood Coagulation Factor [EPC]
  • Increased Coagulation Factor Activity [PE]
  • Blood Coagulation Factors [CS]

NDC Crossover Matching brand name "TISSEEL Frozen" or generic name "Fibrinogen Human And Thrombin Human"

NDCBrand NameGeneric Name
63713-390EVICEL Fibrin Sealant (Human)Fibrinogen Human and Thrombin Human
0944-8402TISSEELfibrinogen human and thrombin human

Trademark Results [TISSEEL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TISSEEL
TISSEEL
73373730 1286760 Live/Registered
Immuno, Aktiengesellschaft fur Chemischmedizinische Produkte
1982-07-09

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