Package 64406-109-01

Brand: qalsody

Generic: tofersen
NDC Package

Package Facts

Identity

Package NDC 64406-109-01
Digits Only 6440610901
Product NDC 64406-109
Description

1 VIAL, SINGLE-USE in 1 CARTON (64406-109-01) / 15 mL in 1 VIAL, SINGLE-USE

Marketing

Marketing Status
Marketed Since 2023-04-25
Brand qalsody
Generic tofersen
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRATHECAL"], "spl_id": "cd6631f3-a134-4743-81b1-ede10394e394", "openfda": {"nui": ["N0000191626", "M0025055"], "upc": ["0364406109010"], "unii": ["2NU6F9601K"], "rxcui": ["2634999", "2635005"], "spl_set_id": ["81356b45-1cb7-4eef-88ea-e44cc18b47c5"], "pharm_class_cs": ["Oligonucleotides, Antisense [CS]"], "pharm_class_epc": ["Antisense Oligonucleotide [EPC]"], "manufacturer_name": ["Biogen Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (64406-109-01)  / 15 mL in 1 VIAL, SINGLE-USE", "package_ndc": "64406-109-01", "marketing_start_date": "20230425"}], "brand_name": "QALSODY", "product_id": "64406-109_cd6631f3-a134-4743-81b1-ede10394e394", "dosage_form": "INJECTION", "pharm_class": ["Antisense Oligonucleotide [EPC]", "Oligonucleotides", "Antisense [CS]"], "product_ndc": "64406-109", "generic_name": "tofersen", "labeler_name": "Biogen Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "QALSODY", "active_ingredients": [{"name": "TOFERSEN", "strength": "100 mg/15mL"}], "application_number": "NDA215887", "marketing_category": "NDA", "marketing_start_date": "20230425", "listing_expiration_date": "20261231"}