Package 64406-058-01

Brand: spinraza

Generic: nusinersen
NDC Package

Package Facts

Identity

Package NDC 64406-058-01
Digits Only 6440605801
Product NDC 64406-058
Description

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

Marketing

Marketing Status
Marketed Since 2016-12-23
Brand spinraza
Generic nusinersen
Sample Package No

Linked Drug Pages (1)

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"}