NDC 64406-008

TYSABRI

Natalizumab

TYSABRI is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Biogen Inc.. The primary component is Natalizumab.

• Product ID: 64406-008_3fdc6d09-d79f-4439-9020-90f7e076088f
• NDC: 64406-008
• Product Type: Human Prescription Drug
• Proprietary Name: TYSABRI
• Generic Name: Natalizumab
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2004-11-23
• Marketing Category: BLA / BLA
• Application Number: BLA125104
• Labeler Name: Biogen Inc.
• Substance Name: NATALIZUMAB
• Active Ingredient Strength: 300 mg/15mL
• Pharm Classes: Integrin Receptor Antagonist [EPC],Integrin Receptor Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 64406-008-01

1 VIAL, SINGLE-USE in 1 CARTON (64406-008-01) > 15 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2004-11-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64406-008-01 [64406000801]

TYSABRI INJECTION

• Marketing Category: BLA
• Application Number: BLA125104
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2004-11-23

Drug Details

Active Ingredients

Ingredient	Strength
NATALIZUMAB	300 mg/15mL

OpenFDA Data

• SPL SET ID: c5fdde91-1989-4dd2-9129-4f3323ea2962
• Manufacturer:
  • Biogen Inc.
• UNII:
  • 3JB47N2Q2P
• RxNorm Concept Unique ID - RxCUI:
  • 603541
  • 477484

Pharmacological Class

• Integrin Receptor Antagonist [EPC]
• Integrin Receptor Antagonists [MoA]