FDA.reportPublic FDA data

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
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SPESOLIMAB300 mg/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5IB2J79MCX
Rxcui2610422, 2610428, 2678979, 2678984, 2716696, 2716697

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e1c7d730-1f8a-459d-b248-0fb8a3a883afProduct name120230626

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0597-7705-38SPEVIGO300 mL in 1 SYRINGEINJECTION3006
0597-7705-41SPEVIGO1 in 1 CARTONINJECTION16
0597-7705-72SPEVIGO2 in 1 CARTONINJECTION26

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2678979spesolimab-sbzo 150 MG in 1 ML Prefilled SyringePSN41a481ee-3062-45d1-aed5-17e8b105634d6
2716696spesolimab-sbzo 300 MG in 2 ML Prefilled SyringePSN41a481ee-3062-45d1-aed5-17e8b105634d6
2610422spesolimab-sbzo 450 MG in 7.5 ML InjectionPSN41a481ee-3062-45d1-aed5-17e8b105634d6
2678984Spevigo 150 MG in 1 ML Prefilled SyringePSN41a481ee-3062-45d1-aed5-17e8b105634d6
2716697Spevigo 300 MG in 2 ML Prefilled SyringePSN41a481ee-3062-45d1-aed5-17e8b105634d6
2610428Spevigo 450 MG in 7.5 ML InjectionPSN41a481ee-3062-45d1-aed5-17e8b105634d6
26789841 ML spesolimab-sbzo 150 MG/ML Prefilled Syringe [Spevigo]SBD41a481ee-3062-45d1-aed5-17e8b105634d6
27166972 ML spesolimab-sbzo 150 MG/ML Prefilled Syringe [Spevigo]SBD41a481ee-3062-45d1-aed5-17e8b105634d6
26104287.5 ML spesolimab-sbzo 60 MG/ML Injection [Spevigo]SBD41a481ee-3062-45d1-aed5-17e8b105634d6
26789791 ML spesolimab-sbzo 150 MG/ML Prefilled SyringeSCD41a481ee-3062-45d1-aed5-17e8b105634d6
27166962 ML spesolimab-sbzo 150 MG/ML Prefilled SyringeSCD41a481ee-3062-45d1-aed5-17e8b105634d6
26104227.5 ML spesolimab-sbzo 60 MG/ML InjectionSCD41a481ee-3062-45d1-aed5-17e8b105634d6
26789841 ML Spevigo 150 MG/ML Prefilled SyringeSY41a481ee-3062-45d1-aed5-17e8b105634d6
26104287.5 ML Spevigo 60 MG/ML InjectionSY41a481ee-3062-45d1-aed5-17e8b105634d6
2678979spesolimab-sbzo 150 MG per 1 ML Prefilled SyringeSY41a481ee-3062-45d1-aed5-17e8b105634d6
2716696spesolimab-sbzo 300 MG per 2 ML Prefilled SyringeSY41a481ee-3062-45d1-aed5-17e8b105634d6
2610422spesolimab-sbzo 450 MG per 7.5 ML InjectionSY41a481ee-3062-45d1-aed5-17e8b105634d6
2678984Spevigo 150 MG per 1 ML Prefilled SyringeSY41a481ee-3062-45d1-aed5-17e8b105634d6
2716697Spevigo 300 MG per 2 ML Prefilled SyringeSY41a481ee-3062-45d1-aed5-17e8b105634d6
2610428Spevigo 450 MG per 7.5 ML InjectionSY41a481ee-3062-45d1-aed5-17e8b105634d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0597-7705-3800597770538300 mL in 1 SYRINGE300 mlHistorical
0597-7705-41005977705411 SYRINGE in 1 CARTON (0597-7705-41) / 300 mL in 1 SYRINGE (0597-7705-38) 1 syringe2025-05-30NoNoCurrent
0597-7705-72005977705722 SYRINGE in 1 CARTON (0597-7705-72) / 300 mL in 1 SYRINGE (0597-7705-38) 2 syringe2025-05-30NoNoCurrent