nemluvio

Generic: nemolizumab-ilto

Labeler: galderma laboratories, l.p.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name nemluvio
Generic Name nemolizumab-ilto
Labeler galderma laboratories, l.p.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

nemolizumab 30 mg/100mg

Manufacturer
Galderma Laboratories, L.P.

Identifiers & Regulatory

Product NDC 0299-6220
Product ID 0299-6220_df0e2be2-b6bd-40e5-9175-0c8e893433ea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761390
Listing Expiration 2026-12-31
Marketing Start 2024-08-13

Pharmacologic Class

Established (EPC)
interleukin-31 receptor alpha antagonist [epc]
Mechanism of Action
interleukin-31 receptor alpha antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02996220
Hyphenated Format 0299-6220

Supplemental Identifiers

RxCUI
2691325 2691328
UNII
GN465U8B72
NUI
N0000194121 N0000194122

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nemluvio (source: ndc)
Generic Name nemolizumab-ilto (source: ndc)
Application Number BLA761390 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 30 mg/100mg
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (0299-6220-10) / 30 mg in 1 SYRINGE, GLASS
  • 1 SYRINGE in 1 CARTON (0299-6220-15) / 30 mg in 1 SYRINGE
source: ndc

Packages (2)

0299-6220-10 1 SYRINGE, GLASS in 1 CARTON (0299-6220-10) / 30 mg in 1 SYRINGE, GLASS 0299-6220-15 1 SYRINGE in 1 CARTON (0299-6220-15) / 30 mg in 1 SYRINGE

Ingredients (1)

nemolizumab (30 mg/100mg)

Linked Drug Pages (1)

NEMLUVIO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "df0e2be2-b6bd-40e5-9175-0c8e893433ea", "openfda": {"nui": ["N0000194121", "N0000194122"], "unii": ["GN465U8B72"], "rxcui": ["2691325", "2691328"], "spl_set_id": ["e9229ef1-ac60-4c24-afb6-009d3c781687"], "pharm_class_epc": ["Interleukin-31 Receptor alpha Antagonist [EPC]"], "pharm_class_moa": ["Interleukin-31 Receptor alpha Antagonists [MoA]"], "manufacturer_name": ["Galderma Laboratories, L.P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 SYRINGE, GLASS in 1 CARTON (0299-6220-10)  / 30 mg in 1 SYRINGE, GLASS", "package_ndc": "0299-6220-10", "marketing_start_date": "20240813"}, {"sample": false, "description": "1 SYRINGE in 1 CARTON (0299-6220-15)  / 30 mg in 1 SYRINGE", "package_ndc": "0299-6220-15", "marketing_start_date": "20240813"}], "brand_name": "NEMLUVIO", "product_id": "0299-6220_df0e2be2-b6bd-40e5-9175-0c8e893433ea", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Interleukin-31 Receptor alpha Antagonist [EPC]", "Interleukin-31 Receptor alpha Antagonists [MoA]"], "product_ndc": "0299-6220", "generic_name": "nemolizumab-ilto", "labeler_name": "Galderma Laboratories, L.P.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NEMLUVIO", "active_ingredients": [{"name": "NEMOLIZUMAB", "strength": "30 mg/100mg"}], "application_number": "BLA761390", "marketing_category": "BLA", "marketing_start_date": "20240813", "listing_expiration_date": "20261231"}