NAXITAMAB
UNII 9K8GNJ2874

Substance Identification & Data

This profile provides standardized clinical and technical data for Naxitamab, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 9K8GNJ2874.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 1879925-92-4 and the RxNorm Concept ID (RxCUI) 2474039. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code

9K8GNJ2874

CAS Registry Number

1879925-92-4

RxNorm Concept ID

2474039

Detailed Substance Profile

Preferred Name

NAXITAMAB

Official standardized name for this substance within the FDA UNII nomenclature system.

Molecular Formula

9K8GNJ2874

The specific atomic composition represented as a molecular structure string.

NCI Thesaurus

C123428

National Cancer Institute reference terminology for clinical and research data.

INN ID

10918

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

protein

ISO 11238 classification category (e.g., Chemical, Polymer, Protein).

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Naxitamab. Identifiers are organized into official regulatory terms, commercial trade names, and technical systematic synonyms used to ensure accurate identification across clinical pharmaceutical databases, regulatory filings, and electronic health records.

FDA Official Name

NAXITAMAB

NAXITAMAB-GQGK

Common Names & Synonyms

ANTI-GD2 IGG3 MONOCLONAL ANTIBODY 3F8 HUMANIZED

ANTI-GD2 MONOCLONAL ANTIBODY 3F8 HUMANIZED

HUMANIZED 3F8

HUMANIZED ANTI-GD2 MONOCLONAL ANTIBODY 3F8

HUMANIZED MONOCLONAL ANTIBODY HU3F8-IGG1

MONOCLONAL ANTIBODY HU3F8

NAXITAMAB [INN]

NAXITAMAB [USAN]

NAXITAMAB [WHO-DD]

NAXITAMAB GQGK [WHO-DD]

Brand / Trade Names

DANYELZA

Systematic Nomenclature

IMMUNOGLOBULIN G1, ANTI-(GANGLIOSIDE GD2) (HUMANIZED MUS MUSCULUS CLONE HU3F8 .GAMMA.1-CHAIN), DISULFIDE WITH HUMANIZED MUS MUSCULUS CLONE HU3F8 LIGHT-CHAIN, DIMER

SYS

IMMUNOGLOBULIN G1-KAPPA, ANTI-(HOMO SAPIENS BETA-1,4 N-ACETYLGALACTOSAMINYLTRANSFERASE 1 ((N-ACETYLNEURAMINYL)-GALACTOSYLGLUCOSYLCERAMIDE, GM2/GD2 SYNTHASE))HUMANIZED MOUSE MONOCLONAL ANTIBODY.GAMMA.1 HEAVY CHAIN (1-449) (MUS MUSCULUS VH (IGHV2-9*02 (79%) (IGHD)-IGHJ3*01 (92%)) (8.6.13) (1-119)-HOMO SAPIENS IGHG1*01 (CH1(K97>R(216)) (120-449)) (222-211')-DISULFIDE WITH .KAPPA. LIGHT CHAIN (1'-211') (MUS MUSCULUS V-KAPPA (IGKV6-32*02 (85%) IGKJ2*03 (90%))(6.3.6)) (1'-104')-HOMO SAPIENS IGKC*01 (105'-211')), DIMER (228-228'':231-231'')-BISDISULFIDE

SYS