qalsody

Generic: tofersen

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

Drug Facts

Product Profile

Brand Name qalsody
Generic Name tofersen
Labeler biogen inc.
Dosage Form INJECTION
Routes
INTRATHECAL
Active Ingredients

tofersen 100 mg/15mL

Manufacturer
Biogen Inc.

Identifiers & Regulatory

Product NDC 64406-109
Product ID 64406-109_cd6631f3-a134-4743-81b1-ede10394e394
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215887
Listing Expiration 2026-12-31
Marketing Start 2023-04-25

Pharmacologic Class

Established (EPC)
antisense oligonucleotide [epc]
Chemical Structure
oligonucleotides, antisense [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64406109
Hyphenated Format 64406-109

Supplemental Identifiers

RxCUI
2634999 2635005
UPC
0364406109010
UNII
2NU6F9601K
NUI
N0000191626 M0025055

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 qalsody (source: ndc)
Generic Name tofersen (source: ndc)
Application Number NDA215887 (source: ndc)
Routes
INTRATHECAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/15mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (64406-109-01) / 15 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

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

Ingredients (1)

tofersen (100 mg/15mL)

Linked Drug Pages (1)

QALSODY ndc-match (0.9)

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"}