spinraza

Generic: nusinersen

Labeler: biogen inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name spinraza
Generic Name nusinersen
Labeler biogen inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRATHECAL
Active Ingredients

nusinersen 2.4 mg/mL

Manufacturer
Biogen Inc.

Identifiers & Regulatory

Product NDC 64406-058
Product ID 64406-058_d0fbae48-8b5a-4dfa-9574-cb1a2d2e7ff8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209531
Listing Expiration 2026-12-31
Marketing Start 2016-12-23

Pharmacologic Class

Established (EPC)
survival motor neuron-2-directed rna interaction [epc] antisense oligonucleotide [epc]
Chemical Structure
oligonucleotides, antisense [cs]
Physiologic Effect
increased protein synthesis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64406058
Hyphenated Format 64406-058

Supplemental Identifiers

RxCUI
1863560 1863565
UNII
5Z9SP3X666
NUI
N0000193222 N0000191626 M0025055 N0000009533

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name spinraza (source: ndc)
Generic Name nusinersen (source: ndc)
Application Number NDA209531 (source: ndc)
Routes
INTRATHECAL
source: ndc

Resolved Composition

Strengths
  • 2.4 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 BOX (64406-058-01) / 5 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

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

Ingredients (1)

nusinersen (2.4 mg/mL)

Linked Drug Pages (1)

Spinraza ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRATHECAL"], "spl_id": "d0fbae48-8b5a-4dfa-9574-cb1a2d2e7ff8", "openfda": {"nui": ["N0000193222", "N0000191626", "M0025055", "N0000009533"], "unii": ["5Z9SP3X666"], "rxcui": ["1863560", "1863565"], "spl_set_id": ["dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94"], "pharm_class_cs": ["Oligonucleotides, Antisense [CS]"], "pharm_class_pe": ["Increased Protein Synthesis [PE]"], "pharm_class_epc": ["Survival Motor Neuron-2-directed RNA Interaction [EPC]", "Antisense Oligonucleotide [EPC]"], "manufacturer_name": ["Biogen Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 BOX (64406-058-01)  / 5 mL in 1 VIAL, SINGLE-USE", "package_ndc": "64406-058-01", "marketing_start_date": "20161223"}], "brand_name": "Spinraza", "product_id": "64406-058_d0fbae48-8b5a-4dfa-9574-cb1a2d2e7ff8", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antisense Oligonucleotide [EPC]", "Increased Protein Synthesis [PE]", "Oligonucleotides", "Antisense [CS]", "Survival Motor Neuron-2-directed RNA Interaction [EPC]"], "product_ndc": "64406-058", "generic_name": "Nusinersen", "labeler_name": "Biogen Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spinraza", "active_ingredients": [{"name": "NUSINERSEN", "strength": "2.4 mg/mL"}], "application_number": "NDA209531", "marketing_category": "NDA", "marketing_start_date": "20161223", "listing_expiration_date": "20261231"}