Spinraza
These highlights do not include all the information needed to use SPINRAZA safely and effectively. See full prescribing information for SPINRAZA. SPINRAZA (nusinersen) injection, for intrathecal useInitial U.S. Approval: 2016
Approved
Approval ID
dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 24, 2023
Manufacturers
FDA
Biogen
DUNS: 121376230
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nusinersen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64406-058
Application NumberNDA209531
Product Classification
M
Marketing Category
C73594
G
Generic Name
Nusinersen
Product Specifications
Route of AdministrationINTRATHECAL
Effective DateDecember 21, 2022
FDA Product Classification
INGREDIENTS (8)
NusinersenActive
Quantity: 2.4 mg in 1 mL
Code: 5Z9SP3X666
Classification: ACTIB
Sodium phosphate, monobasic, dihydrateInactive
Quantity: 0.05 mg in 1 mL
Code: 5QWK665956
Classification: IACT
Sodium phosphate, dibasic, anhydrousInactive
Quantity: 0.10 mg in 1 mL
Code: 22ADO53M6F
Classification: IACT
Sodium ChlorideInactive
Quantity: 8.77 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
Potassium ChlorideInactive
Quantity: 0.22 mg in 1 mL
Code: 660YQ98I10
Classification: IACT
Magnesium chlorideInactive
Quantity: 0.16 mg in 1 mL
Code: 02F3473H9O
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Calcium chlorideInactive
Quantity: 0.21 mg in 1 mL
Code: M4I0D6VV5M
Classification: IACT