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

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

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 · 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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761390Nemluvionemolizumab-ilto351(a)Rx2026-07-01

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