FDA.reportPublic FDA data

SPEVIGO

Product NDC
0597-0035
11-digit product format
005970035
Labeler code
0597
Product ID
0597-0035_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
2022-09-01
Marketing end
2027-11-30
Substance
SPESOLIMAB
Active strength
60 mg/mL
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
IngredientStrength
SPESOLIMAB60 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5IB2J79MCXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2610422Internal RxNorm lookup
2610428Internal RxNorm lookup
2678979Internal RxNorm lookup
2678984Internal RxNorm lookup
2716696Internal RxNorm lookup
2716697Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
41a481ee-3062-45d1-aed5-17e8b105634dAvailable on FDA.report

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
0597-0035-10SPEVIGO2 in 1 CARTONINJECTION26
0597-0035-10SPEVIGO7.5 mL in 1 VIAL, GLASSINJECTION7.56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0035-10ML - Milliliter0597-003519291499-1ab1-4e98-b0e5-ca16a071d29312022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0597-0035SPEVIGO (SPESOLIMAB-SBZO) INJECTION [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 2 package rows20241215_41a481ee-3062-45d1-aed5-17e8b105634d.zip

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPEVIGOSPESOLIMAB-SBZOBoehringer Ingelheim Pharmaceuticals, Inc.41a481ee-3062-45d1-aed5-17e8b105634d2026-04-08Warnings, Adverse reactionsExact identifier
application number: BLA761244
ndc (product): 0597-0035
SPEVIGOSPESOLIMABLEO Pharma Inc.78a4f7eb-8d34-4467-8d40-74ed243238062026-03-16Warnings, Adverse reactionsExact identifier
application number: BLA761244

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761244Spevigospesolimab-sbzo351(a)Rx2026-06-01

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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0597-0035-10005970035102 VIAL, GLASS in 1 CARTON (0597-0035-10) / 7.5 mL in 1 VIAL, GLASS2022-09-010000-00-00NoNoCurrent