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Active ingredient

Trastuzumab

14 finished FDA listings contain Trastuzumab as their only active ingredient; 3 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
TRASTUZUMAB, TRASTUZUMAB DERUXTECAN, TRASTUZUMAB EMTANSINE, TRASTUZUMAB-QYYP, TRASTUZUMAB-STRF
Dosage forms
Injection, Powder, Lyophilized, For Solution
Routes
Intravenous
Manufacturers / labelers
9
Strengths listed
100 mg/5ml · 150 mg/1 · 150 mg/7.15ml · 150 mg/7.4ml · 20 mg/ml · 420 mg/20ml
Brand names in FDA listings
Enhertu, Herceptin, Hercessi, Herzuma, Kadcyla, Kanjinti, Ogivri, Ontruzant, Trazimera

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 224905

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
BLA 103792GENENTECH1998-09-251
BLA 125427GENENTECH2013-02-222
BLA 761074MYLAN GMBH2017-12-013
BLA 761091CELLTRION INC2018-12-141
BLA 761100SAMSUNG BIOEPIS CO LTD2019-01-181
BLA 761081PFIZER INC2019-03-111
BLA 761073AMGEN INC2019-06-132
BLA 761139DAIICHI SANKYO2019-12-201
BLA 761346ACCORD BIOPHARMA INC.2024-04-252

Official labeling on DailyMed

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.