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 ID: 0338-8503_23ddd9a6-b64c-49b4-9863-d164f6aad1dc
• NDC: 0338-8503
• Product Type: Plasma Derivative
• Proprietary Name: ARTISS Fibrin Sealant
• Generic Name: Fibrinogen Human, Human Thrombin
• Dosage Form: Solution
• Route of Administration: TOPICAL
• Marketing Start Date: 2008-03-19
• Marketing Category: BLA / BLA
• Application Number: BLA125266
• Labeler Name: Baxter Healthcare Corporation
• Substance Name: FIBRINOGEN HUMAN; HUMAN THROMBIN
• Active Ingredient Strength: 90 mg/mL; [iU]/mL
• Pharm Classes: 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 Exclude Flag: N
• Listing Certified Through: 2021-12-31

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 Date: 2008-03-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0338-8503-01 [00338850301]

ARTISS Fibrin Sealant SOLUTION

• Marketing Category: BLA
• Application Number: BLA125266
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2008-03-19

NDC 0338-8503-10 [00338850310]

ARTISS Fibrin Sealant SOLUTION

• Marketing Category: BLA
• Application Number: BLA125266
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2008-03-19

NDC 0338-8503-02 [00338850302]

ARTISS Fibrin Sealant SOLUTION

• Marketing Category: BLA
• Application Number: BLA125266
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2008-03-19

NDC 0338-8503-03 [00338850303]

ARTISS Fibrin Sealant SOLUTION

• Marketing Category: BLA
• Application Number: BLA125266
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2008-03-19

NDC 0338-8503-04 [00338850304]

ARTISS Fibrin Sealant SOLUTION

• Marketing Category: BLA
• Application Number: BLA125266
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2008-03-19

NDC 0338-8503-09 [00338850309]

ARTISS Fibrin Sealant SOLUTION

• Marketing Category: BLA
• Application Number: BLA125266
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2008-03-19

Drug Details

Active Ingredients

Ingredient	Strength
FIBRINOGEN HUMAN	90 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"

NDC	Brand Name	Generic Name
0338-8503	ARTISS	Fibrinogen Human, Human Thrombin
0338-9637	ARTISS	Fibrinogen Human, Human Thrombin
0338-9639	ARTISS	Fibrinogen Human, Human Thrombin
0338-4210	TISSEEL	fibrinogen human, human thrombin
0338-4211	TISSEEL	fibrinogen human, human thrombin
0338-4212	TISSEEL	fibrinogen human, human thrombin
0338-4301	TISSEEL	fibrinogen human, human thrombin
0338-4302	TISSEEL	fibrinogen human, human thrombin
0338-4303	TISSEEL	fibrinogen human, human thrombin
0338-8402	TISSEEL	fibrinogen human, human thrombin
0338-9560	TISSEEL	fibrinogen human, human thrombin
0338-9564	TISSEEL	fibrinogen human, human thrombin
0338-9568	TISSEEL	fibrinogen human, human thrombin