TRASTUZUMAB ENVEDOTIN
UNII 37DMF82G1F

Substance Identification & Data

This profile provides standardized clinical and technical data for Trastuzumab Envedotin, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 37DMF82G1F.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 2865132-89-2 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

37DMF82G1F

CAS Registry Number

2865132-89-2

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

TRASTUZUMAB ENVEDOTIN

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

NCI Thesaurus

C173962

National Cancer Institute reference terminology for clinical and research data.

INN ID

13009

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Trastuzumab Envedotin

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

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Trastuzumab Envedotin. 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

Trastuzumab Envedotin

Common Names & Synonyms

H-gamma1 heavy chain humanized (1-450) [VH (Homo sapiens IGHV3-66*01 (81.6%) -(IGHD) -IGHJ4*01 (100%), CDR-IMGT [8.8.13] (26-33.51-58.97-109)) (1-120) -Homo sapiens IGHG1*03v, G1m3>G1m17, nG1m1 CH1 K120, CH3 E12, M14 (CH1 R120>K (217) (121-218), hinge 1-15 (219-233), CH2 (234-343), CH3 E12 (359), M14 (361) (344-448), CHS (449-450)) (121-450)], (223-214')-disulfide with L-kappa light chain humanized (1'-214') [V-KAPPA (Homo sapiens IGKV1-39*01 (86.3%) -IGKJ1*01 (100%), CDR-IMGT [6.3.9] (27'-32'.50'-52'.89'-97')) (1'-107') -Homo sapiens IGKC*01 (100%), Km3 A45.1 (153'), V101 (191') (108'-214')]; dimer (229-229'':232-232'')-bisdisulfide, produced in Chinese hamster ovary (CHO) cells, glycoform alfa; substituted at the side chain nitrogen atom of L-glutaminyl residues 298 and 298'' with a radical group consisting of (6S,9S)-1-amino-6-({4-[(5S,8S,11S,12R)-11-[(2S)-butan-2-yl]-12-(2-{(2S)-2-[(1R,2R)-3-{[(1S,2R)-1-hydroxy-1-phenylpropan-2-yl]amino}-1-methoxy-2-methyl-3-oxopropyl]pyrrolidin-1-yl}-2-oxoethyl)-4,10-dimethyl-3,6,9-trioxo-5,8-di(propan-2-yl)-2,13-dioxa-4,7,10-triazatetradecyl]phenyl}carbamoyl)-1,8,11-trioxo-9-(propan-2-yl)-13,16,19-trioxa-2,7,10-triazahenicosan-21-yl (envedotin)

Immunoglobulin G1, anti-(human epidermal growth factor receptor HER2) (human-Mus musculus monoclonal DP001 γ1-chain), disulfide with human-Mus musculus monoclonal DP001 κ-chain, dimer, 298,298′-diamide with N-[[[4-[[N-[2-[2-[2-(2-aminoethoxy)ethoxy]ethoxy]acetyl]-L-valyl-N5-(aminocarbonyl)-L-ornithyl]amino]phenyl]methoxy]carbonyl]-N-methyl-L-valyl-N-[(1S,2R)-4-[(2S)-2-[(1R,2R)-3-[[(1R,2S)-2-hydroxy-1-methyl-2-phenylethyl]amino]-1-methoxy-2-methyl-3-oxopropyl]-1-pyrrolidinyl]-2-methoxy-1-[(1S)-1-methylpropyl]-4-oxobutyl]-N-methyl-L-valinamide

immunoglobulin G1-kappa, anti-[Homo sapiens ERBB2 (receptor tyrosine-protein kinase erbB-2, epidermal growth factor receptor 2, EGFR2, HER2, HER-2, p185c-erbB2, NEU, CD340)], humanized monoclonal antibody, conjugated at glutaminyl residues to monomethylauristatin E (MMAE), with a ratio of 1 to 2, via a cleavable linker

trastuzumab envedotin [INN]