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United States · US · US:50222-362_40cef378-e90e-4891-812a-b3c889dc9193
SPEVIGO
UNIISPLATC L04AC22
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLEO Pharma Inc.
CountryUS (United States)
ATC codeL04AC22
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1150222362011 SYRINGE, GLASS in 1 CARTON (50222-362-01) / 2 mL in 1 SYRINGE, GLASS (50222-362-12)
- ndc1150222362022 SYRINGE, GLASS in 1 CARTON (50222-362-02) / 2 mL in 1 SYRINGE, GLASS (50222-362-12)
Annotations
UNII (FDA Substance ID)
5IB2J79MCX
SPESOLIMAB
RxCUI 2610417
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5IB2J79MCX",
"rxcui": "2610417",
"inchikey": null,
"display_name": "SPESOLIMAB",
"substance_type": "protein",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"78a4f7eb-8d34-4467-8d40-74ed24323806": {
"match": "brand_token",
"title": "SPEVIGO (SPESOLIMAB) INJECTION [LEO PHARMA INC.]",
"spl_version": "2",
"published_date": "2026-03-19"
}
},
"productid": "50222-362_40cef378-e90e-4891-812a-b3c889dc9193",
"productndc": "50222-362",
"dosage_form": "INJECTION",
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SPESOLIMAB",
"proprietary_name": "SPEVIGO",
"active_ingred_unit": "mg/2mL",
"application_number": "BLA761244",
"marketing_category": "BLA",
"nonproprietary_name": "spesolimab",
"start_marketing_date": "20260309",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code L04AC22.
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