TYSABRI
These highlights do not include all the information needed to use TYSABRI safely and effectively. See full prescribing information for TYSABRI.TYSABRI (natalizumab) injection, for intravenous useInitial U.S. Approval: 2004
Approved
Approval ID
c5fdde91-1989-4dd2-9129-4f3323ea2962
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 27, 2023
Manufacturers
FDA
Biogen Inc.
DUNS: 121376230
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
natalizumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64406-008
Application NumberBLA125104
Product Classification
M
Marketing Category
C73585
G
Generic Name
natalizumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 22, 2022
FDA Product Classification
INGREDIENTS (6)
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
sodium phosphate, monobasic, monohydrateInactive
Code: 593YOG76RN
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
natalizumabActive
Quantity: 300 mg in 15 mL
Code: 3JB47N2Q2P
Classification: ACTIB
sodium phosphate, dibasic, heptahydrateInactive
Code: 70WT22SF4B
Classification: IACT