Home NDC 0597-7705 SPEVIGO
Product NDC 0597-7705
11-digit product format 005977705
Labeler code 0597
Product ID 0597-7705_31184b4e-682f-45ba-9e4f-332bc1df45b8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name spesolimab-sbzo
Dosage form INJECTION
Route INTRAVENOUS
Labeler Boehringer Ingelheim Pharmaceuticals, Inc.
Application BLA761244
Marketing category BLA
Marketing start 2025-05-28
Marketing end 2027-04-30
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 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base SPEVIGO Active Ingredients# Ingredient, Strength table Ingredient Strength SPESOLIMAB 300 mg/1
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 0597-7705-38 SPEVIGO 300 mL in 1 SYRINGE INJECTION 300 6 0597-7705-41 SPEVIGO 1 in 1 CARTON INJECTION 1 6 0597-7705-72 SPEVIGO 2 in 1 CARTON INJECTION 2 6
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 Marketing end Sample Exclude flag Status 0597-7705-38 00597770538 300 mL in 1 SYRINGE 300 ml Historical 0597-7705-41 00597770541 1 SYRINGE in 1 CARTON (0597-7705-41) / 300 mL in 1 SYRINGE (0597-7705-38) 1 syringe 2025-05-30 2027-04-30 No No Historical 0597-7705-72 00597770572 2 SYRINGE in 1 CARTON (0597-7705-72) / 300 mL in 1 SYRINGE (0597-7705-38) 2 syringe 2025-05-30 2027-04-30 No No Historical