NDC 0338-8503

ARTISS Fibrin Sealant

Fibrinogen Human, Human Thrombin

ARTISS Fibrin Sealant is a Topical Solution in the Plasma Derivative category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is Fibrinogen Human; Human Thrombin.

Product ID0338-8503_23ddd9a6-b64c-49b4-9863-d164f6aad1dc
NDC0338-8503
Product TypePlasma Derivative
Proprietary NameARTISS Fibrin Sealant
Generic NameFibrinogen Human, Human Thrombin
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2008-03-19
Marketing CategoryBLA / BLA
Application NumberBLA125266
Labeler NameBaxter Healthcare Corporation
Substance NameFIBRINOGEN HUMAN; HUMAN THROMBIN
Active Ingredient Strength90 mg/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
Listing Certified Through2021-12-31

Packaging

NDC 0338-8503-02

1 SYRINGE, PLASTIC in 1 CARTON (0338-8503-02) > 2 mL in 1 SYRINGE, PLASTIC (0338-8503-01)
Marketing Start Date2008-03-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0338-8503-01 [00338850301]

ARTISS Fibrin Sealant SOLUTION
Marketing CategoryBLA
Application NumberBLA125266
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2008-03-19

NDC 0338-8503-10 [00338850310]

ARTISS Fibrin Sealant SOLUTION
Marketing CategoryBLA
Application NumberBLA125266
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2008-03-19

NDC 0338-8503-02 [00338850302]

ARTISS Fibrin Sealant SOLUTION
Marketing CategoryBLA
Application NumberBLA125266
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2008-03-19

NDC 0338-8503-03 [00338850303]

ARTISS Fibrin Sealant SOLUTION
Marketing CategoryBLA
Application NumberBLA125266
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2008-03-19

NDC 0338-8503-04 [00338850304]

ARTISS Fibrin Sealant SOLUTION
Marketing CategoryBLA
Application NumberBLA125266
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2008-03-19

NDC 0338-8503-09 [00338850309]

ARTISS Fibrin Sealant SOLUTION
Marketing CategoryBLA
Application NumberBLA125266
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2008-03-19

Drug Details

Active Ingredients

IngredientStrength
FIBRINOGEN HUMAN90 mg/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 "ARTISS Fibrin Sealant" or generic name "Fibrinogen Human, Human Thrombin"

NDCBrand NameGeneric Name
0338-8503ARTISSFibrinogen Human, Human Thrombin
0338-9637ARTISSFibrinogen Human, Human Thrombin
0338-9639ARTISSFibrinogen Human, Human Thrombin
0338-4210TISSEELfibrinogen human, human thrombin
0338-4211TISSEELfibrinogen human, human thrombin
0338-4212TISSEELfibrinogen human, human thrombin
0338-4301TISSEELfibrinogen human, human thrombin
0338-4302TISSEELfibrinogen human, human thrombin
0338-4303TISSEELfibrinogen human, human thrombin
0338-8402TISSEELfibrinogen human, human thrombin
0338-9560TISSEELfibrinogen human, human thrombin
0338-9564TISSEELfibrinogen human, human thrombin
0338-9568TISSEELfibrinogen human, human thrombin

Trademark Results [ARTISS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ARTISS
ARTISS
78514937 3502970 Live/Registered
Baxter International Inc.
2004-11-10

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