FDA.reportPublic FDA data

NEMLUVIO

Product NDC
0299-6220
11-digit product format
002996220
Labeler code
0299
Product ID
0299-6220_df0e2be2-b6bd-40e5-9175-0c8e893433ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nemolizumab-ilto
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
SUBCUTANEOUS
Labeler
Galderma Laboratories, L.P.
Application
BLA761390
Marketing category
BLA
Marketing start
2024-08-13
Substance
NEMOLIZUMAB
Active strength
30 mg/100mg
Pharmacologic classes
Interleukin-31 Receptor alpha Antagonist [EPC], Interleukin-31 Receptor alpha Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NEMLUVIONEMOLIZUMAB-ILTOGalderma Laboratories, L.P.e9229ef1-ac60-4c24-afb6-009d3c7816872025-06-26Warnings, Adverse reactionsExact identifier
application number: BLA761390
ndc (product): 0299-6220

Additional Listing Data#

Finished product
Yes
Brand name base
NEMLUVIO
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEMOLIZUMAB30 mg/100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
GN465U8B72Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2691325Internal RxNorm lookup
2691328Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e9229ef1-ac60-4c24-afb6-009d3c781687Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
6c197cc8-c532-49f8-b74c-395e0a65747dProduct name120250317

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0299-6220-10NEMLUVIO30 mg in 1 SYRINGE, GLASSINJECTION, POWDER, LYOPHILIZED,305
0299-6220-10NEMLUVIO1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,15
0299-6220-15NEMLUVIO1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,15
0299-6220-15NEMLUVIO30 mg in 1 SYRINGEINJECTION, POWDER, LYOPHILIZED,305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0299-6220-10EA - Each0299-6220faed19f5-cd81-4cd3-8637-238874234acb12025-11-13
0299-6220-15EA - Each0299-6220c2c0a094-43a9-4f6d-813f-b088a16bcfb312024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-6220NEMLUVIO (NEMOLIZUMAB-ILTO) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GALDERMA LABORATORIES, L.P.]3Current NDC, 4 package rows20250507_e9229ef1-ac60-4c24-afb6-009d3c781687.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761390Nemluvionemolizumab-ilto351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2691328nemluvio 30 MG Auto-InjectorPSNe9229ef1-ac60-4c24-afb6-009d3c7816875
2691325nemolizumab-ilto 30 MG Auto-InjectorPSNe9229ef1-ac60-4c24-afb6-009d3c7816875
2691328nemolizumab-ilto 30 MG Auto-Injector [Nemluvio]SBDe9229ef1-ac60-4c24-afb6-009d3c7816875
2691325nemolizumab-ilto 30 MG Auto-InjectorSCDe9229ef1-ac60-4c24-afb6-009d3c7816875
2691328Nemluvio 30 MG Auto-InjectorSYe9229ef1-ac60-4c24-afb6-009d3c7816875

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0299-6220-10002996220101 SYRINGE, GLASS in 1 CARTON (0299-6220-10) / 30 mg in 1 SYRINGE, GLASS2024-08-13YesNoCurrent
0299-6220-15002996220151 SYRINGE in 1 CARTON (0299-6220-15) / 30 mg in 1 SYRINGE1 syringe2024-08-13NoNoCurrent