Home NDC 50222-362 SPEVIGO
Product NDC 50222-362
11-digit product format 502220362
Labeler code 50222
Product ID 50222-362_40cef378-e90e-4891-812a-b3c889dc9193
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name spesolimab
Dosage form INJECTION
Route SUBCUTANEOUS
Labeler LEO Pharma Inc.
Application BLA761244
Marketing category BLA
Marketing start 2026-03-09
Substance SPESOLIMAB
Active strength 300 mg/2mL
Pharmacologic classes Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base SPEVIGO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SPESOLIMAB 300 mg/2mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5IB2J79MCX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2610422 Internal RxNorm lookup 2610428 Internal RxNorm lookup 2678979 Internal RxNorm lookup 2678984 Internal RxNorm lookup 2716696 Internal RxNorm lookup 2716697 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50222-362-01 SPEVIGO 1 in 1 CARTON INJECTION 1 2 50222-362-02 SPEVIGO 2 in 1 CARTON INJECTION 2 2 50222-362-12 SPEVIGO 2 mL in 1 SYRINGE, GLASS INJECTION 2 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761244 Spevigo spesolimab-sbzo 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50222-362-01 50222036201 1 SYRINGE, GLASS in 1 CARTON (50222-362-01) / 2 mL in 1 SYRINGE, GLASS (50222-362-12) 2026-03-09 No No Current 50222-362-02 50222036202 2 SYRINGE, GLASS in 1 CARTON (50222-362-02) / 2 mL in 1 SYRINGE, GLASS (50222-362-12) 2026-03-09 No No Current 50222-362-12 50222036212 2 mL in 1 SYRINGE, GLASS 2 ml Historical