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
NDC Product Code64406-058
Application NumberNDA209531
Marketing CategoryC73594
Route of AdministrationINTRATHECAL
Effective DateDecember 21, 2022
Generic NameNusinersen
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