NDC 0944-8503

ARTISS Frozen

Fibrinogen Human Thrombin Human

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

• Product ID: 0944-8503_183b59f6-1e19-4a35-86f2-b2e77fdb2709
• NDC: 0944-8503
• Product Type: Human Prescription Drug
• Proprietary Name: ARTISS Frozen
• Generic Name: Fibrinogen Human Thrombin Human
• Dosage Form: Solution
• Route of Administration: TOPICAL
• Marketing Start Date: 2011-01-11
• Marketing End Date: 2019-06-30
• Marketing Category: BLA / BLA
• Application Number: BLA125266
• Labeler Name: Baxalta US Inc.
• 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

Packaging

NDC 0944-8503-10

1 SYRINGE, PLASTIC in 1 CARTON (0944-8503-10) > 10 mL in 1 SYRINGE, PLASTIC

• Marketing Start Date: 2011-01-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0944-8503-04 [00944850304]

ARTISS Frozen SOLUTION

• Marketing Category: BLA
• Application Number: BLA125266
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2008-03-08
• Marketing End Date: 2019-07-31

NDC 0944-8503-10 [00944850310]

ARTISS Frozen SOLUTION

• Marketing Category: BLA
• Application Number: BLA125266
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-01-11
• Marketing End Date: 2019-06-30

NDC 0944-8503-02 [00944850302]

ARTISS Frozen SOLUTION

• Marketing Category: BLA
• Application Number: BLA125266
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2009-03-19
• Marketing End Date: 2019-06-30

Drug Details

Active Ingredients

Ingredient	Strength
FIBRINOGEN HUMAN	90 mg/mL

OpenFDA Data

• SPL SET ID: 13f76667-ec2f-4fa7-a9e8-12502d8224db
• Manufacturer:
  • Baxalta US Inc.
• UNII:
  • 6K15ABL77G
  • N94833051K
• RxNorm Concept Unique ID - RxCUI:
  • 1305892
  • 1305891
  • 1305890
  • 1305907
  • 1305888
  • 1305908
  • 1305910
  • 1305909

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]