ROLDITAMIG
UNII P65E8F9MZV

Substance Identification & Data

This profile provides standardized clinical and technical data for Rolditamig, uniquely identified by the FDA Unique Ingredient Identifier (UNII) P65E8F9MZV.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 3038136-62-5 and the RxNorm Concept ID (RxCUI) N/A. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code

P65E8F9MZV

CAS Registry Number

3038136-62-5

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

ROLDITAMIG

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

INN ID

14031

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 Rolditamig. 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

ROLDITAMIG

Common Names & Synonyms

IMMUNOGLOBULIN (H-GAMMA1_L-KAPPA)_SCFVHK-G1(H-CH2-CH3), ANTI-(HOMO SAPIENS ERBB2 (RECEPTOR TYROSINE-PROTEIN KINASE ERBB-2, EPIDERMAL GROWTH FACTOR RECEPTOR 2, EGFR2, HER2, HER-2, P185C-ERBB2, NEU, CD340) EXTRACELLULAR DOMAINS 2 AND 4), HUMANIZED MONOCLONAL ANTIBODY, BIPARATOPIC (ROLDITAMIG)

IMMUNOGLOBULIN, ANTI-(HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR HER2 EXTRACELLULAR DOMAIN 4) (HUMAN-MUS MUSCULUS MONOCLONAL RHUMAB 2C4 SINGLE-CHAIN VARIABLE FRAGMENT VH-(GGGGS)4-VL) FUSION PROTEIN WITH IMMUNOGLOBULIN G1 (5-SERINE,139-CYSTEINE,150-TRYPTOPHAN) (HUMAN .GAMMA.1-CHAIN HINGE-CH2-CH3 FRAGMENT), (259->228'),(262->231'),(387->351')-TRIS(DISULFIDE) WITH IMMUNOGLOBULIN G1 (216-LYSINE,351-CYSTEINE,368-SERINE,370-ALANINE,409-VALINE,437-ARGININE,438-PHENYLALANINE) ANTI-(HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR HER2 EXTRACELLULAR DOMAIN 2) (HUMAN-MUS MUSCULUS MONOCLONAL HUM-AB4D5-8 .GAMMA.1-CHAIN), (222'->214'')-DISULFIDE WITH (HUMAN-MUS MUSCULUS MONOCLONAL HUM-AB4D5-8 .KAPPA.-CHAIN)

ROLDITAMIG [INN]

External Clinical & Regulatory Resources

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