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NDC 64406-0008-01 TYSABRI 300 mg/15mL Details
TYSABRI 300 mg/15mL
TYSABRI is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Biogen Inc.. The primary component is NATALIZUMAB.
MedlinePlus Drug Summary
Natalizumab is used to prevent episodes of symptoms and slow the worsening of disability in adults who have relapsing forms of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control), including: clinically isolated syndrome (CIS; first nerve symptom episode that lasts at least 24 hours), relapsing-remitting disease (course of disease where symptoms flare up from time to time), active secondary progressive disease (later stage of disease with continuous worsening of symptoms.) Natalizumab is also used to treat and prevent episodes of symptoms in adults who have Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) who have not been helped by other medications or who cannot take other medications. Natalizumab is in a class of medications called monoclonal antibodies. It works by stopping certain cells of the immune system from reaching the brain and spinal cord or digestive tract and causing damage.
Related Packages: 64406-0008-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Natalizumab Injection
Product Information
NDC | 64406-0008 |
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Product ID | 64406-008_c7e88fc5-9622-4d43-9af9-42f4e77c3c4f |
Associated GPIs | 62405050001320 |
GCN Sequence Number | 058384 |
GCN Sequence Number Description | natalizumab VIAL 300MG/15ML INTRAVEN |
HIC3 | Z2R |
HIC3 Description | LEUKOCYTE ADHESION INHIB,ALPHA4-MEDIAT IGG4K MC AB |
GCN | 23805 |
HICL Sequence Number | 026750 |
HICL Sequence Number Description | NATALIZUMAB |
Brand/Generic | Brand |
Proprietary Name | TYSABRI |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | natalizumab |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INJECTION |
Route | INTRAVENOUS |
Active Ingredient Strength | 300 |
Active Ingredient Units | mg/15mL |
Substance Name | NATALIZUMAB |
Labeler Name | Biogen Inc. |
Pharmaceutical Class | Integrin Receptor Antagonist [EPC], Integrin Receptor Antagonists [MoA] |
DEA Schedule | n/a |
Marketing Category | BLA |
Application Number | BLA125104 |
Listing Certified Through | 2024-12-31 |
Package
NDC 64406-0008-01 (64406000801)
NDC Package Code | 64406-008-01 |
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Billing NDC | 64406000801 |
Package | 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 |
Pricing Information | N/A |