NDC 64406-058

Spinraza

Nusinersen

Spinraza is a Intrathecal Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Biogen. The primary component is Nusinersen.

• Product ID: 64406-058_1b045c33-0852-4f15-aac0-834efcaf144a
• NDC: 64406-058
• Product Type: Human Prescription Drug
• Proprietary Name: Spinraza
• Generic Name: Nusinersen
• Dosage Form: Injection, Solution
• Route of Administration: INTRATHECAL
• Marketing Start Date: 2016-12-23
• Marketing Category: NDA / NDA
• Application Number: NDA209531
• Labeler Name: Biogen
• Substance Name: NUSINERSEN
• Active Ingredient Strength: 2 mg/mL
• Pharm Classes: Survival Motor Neuron-2-directed RNA Interaction [EPC],Antisense Oligonucleotide [EPC],Oligonucleotides, Antisense [CS],Increased Protein Synthesis [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 64406-058-01

1 VIAL, SINGLE-USE in 1 BOX (64406-058-01) > 5 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2016-12-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64406-058-01 [64406005801]

Spinraza INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA209531
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-12-23

Drug Details

Active Ingredients

Ingredient	Strength
NUSINERSEN	2.4 mg/mL

OpenFDA Data

• SPL SET ID: dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94
• Manufacturer:
  • Biogen
• UNII:
  • 5Z9SP3X666
• RxNorm Concept Unique ID - RxCUI:
  • 1863565
  • 1863560

Pharmacological Class

• Survival Motor Neuron-2-directed RNA Interaction [EPC]
• Antisense Oligonucleotide [EPC]
• Oligonucleotides
• Antisense [CS]
• Increased Protein Synthesis [PE]