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United States · US · US:64406-109_cd6631f3-a134-4743-81b1-ede10394e394
QALSODY
Orange BookUNIISPLATC N07XX22
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBiogen Inc.
CountryUS (United States)
ATC codeN07XX22
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1164406109011 VIAL, SINGLE-USE in 1 CARTON (64406-109-01) / 15 mL in 1 VIAL, SINGLE-USE
Annotations
UNII (FDA Substance ID)
2NU6F9601K
TOFERSEN
Orange Book
N215887
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2NU6F9601K",
"rxcui": null,
"inchikey": null,
"display_name": "TOFERSEN",
"substance_type": "nucleicAcid",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRATHECAL",
"spl_meta": {
"81356b45-1cb7-4eef-88ea-e44cc18b47c5": {
"match": "brand_token",
"title": "QALSODY (TOFERSEN) INJECTION [BIOGEN INC.]",
"spl_version": "3",
"published_date": "2024-11-18"
}
},
"productid": "64406-109_cd6631f3-a134-4743-81b1-ede10394e394",
"productndc": "64406-109",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "215887",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG/15ML (6.7MG/ML)",
"product_no": "001",
"approval_date": "Apr 25, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOFERSEN",
"proprietary_name": "QALSODY",
"active_ingred_unit": "mg/15mL",
"application_number": "NDA215887",
"marketing_category": "NDA",
"nonproprietary_name": "tofersen",
"start_marketing_date": "20230425",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N07XX22.
- ISQalsodyBiogen Netherlands B.V.
- DKQalsodyBiogen Netherlands B.V.
- FIQalsodyBiogen Netherlands B.V.
- CZQALSODYBiogen Netherlands B.V., Badhoevedorp
- BEQalsody 100 mgBiogen Netherlands
- NLQalsody 100 mg oplossing voor injectieBiogen Netherlands B.V.
- PLQalsody 100 mg roztwór do wstrzykiwańBiogen Netherlands B.V.
- 🇪🇸QALSODY 100 MG SOLUCIÓN INYECTABLEBiogen Netherlands B.V.
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