TRASTUZUMAB BULTECAN
UNII QW54UB3V97

Substance Identification & Data

This profile provides standardized clinical and technical data for Trastuzumab Bultecan, uniquely identified by the FDA Unique Ingredient Identifier (UNII) QW54UB3V97.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 3033451-22-5 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

QW54UB3V97

CAS Registry Number

3033451-22-5

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

TRASTUZUMAB BULTECAN

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

NCI Thesaurus

C224798

National Cancer Institute reference terminology for clinical and research data.

INN ID

13660

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Trastuzumab Bultecan

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 Bultecan. 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 Bultecan

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, V101 (C-KAPPA A45.1 (153'), V101 (191')) (108'-214')]; dimer (229-229'':232-232'')-bisdisulfide, produced in Chinese hamster ovary (CHO) cells, cell line CHO-K1SV, lacking the glutamine synthetase (GS-KO) gene, glycoform alfa; substituted at the sulfur atoms of the L-cysteinyl residues 223, 229, 232, 214', 223'', 229'', 232'' and 214''' with (3RS)-1-[(9S,12S,15S)-1-[(4S)-4-ethyl-8-fluoro-4-hydroxy-9-methyl-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-10-yl]-9-methyl-8,11,14,17-tetraoxo-15-(3-oxo-3-{[(2S,3R,4R,5R)-2,3,4,5,6-pentahydroxyhexyl]amino}propyl)-12-(propan-2-yl)-5-oxa-7,10,13,16-tetraazadocosan-22-yl]-2,5-dioxopyrrolidin-3-yl (bultecan) groups

Immunoglobulin G1, anti-(human epidermal growth factor receptor HER2) (human-Mus musculus monoclonal rhuMab HER2 γ1-chain), complex with human-Mus musculus monoclonal rhuMab HER2 κ-chain, dimer, octakis(thioether) with N5-(1-deoxy-D-glucitol-1-yl)-N2-[6-(3-mercapto-2,5-dioxo-1-pyrrolidinyl)-1-oxohexyl]-L-glutaminyl-L-valyl-N-[[4-[(4S)-4-ethyl-8-fluoro-3,4,12,14-tetrahydro-9-methyl-4-hydroxy-3,14-dioxo-1H-pyrano[3′,4′:6,7]indolizino[1,2-b]quinolin-10-yl]butoxy]methyl]-L-alaninamide

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 on an average of eight cysteinyl residues to bultecan groups, comprising a linker and a camptothecin derivative (trastuzumab bultecan)

trastuzumab bultecan [INN]

External Clinical & Regulatory Resources

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