Quick answers
- What is Trastuzumab used for?
- The FDA-approved label (Herceptin, Genentech, Inc., May 29, 2026) says: “Herceptin is a HER2/neu receptor antagonist indicated in adults for: The treatment of HER2-overexpressing breast cancer. ( 1.1, 1.2 ) The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Select patients for therapy based on an FDA-authorized companion diagnostic for Herceptin ( 1, 2.2 ). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Trastuzumab have a boxed warning?
- Yes. The FDA label for Herceptin has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Trastuzumab?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Trastuzumab been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Trastuzumab?
- 7 companies list prescription products of Trastuzumab in the FDA NDC Directory, including Biocon Biologics Inc., Amgen, Inc and Mylan Institutional LLC.
What Trastuzumab is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Herceptin is a HER2/neu receptor antagonist indicated in adults for: The treatment of HER2-overexpressing breast cancer. ( 1.1, 1.2 ) The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Select patients for therapy based on an FDA-authorized companion diagnostic for Herceptin ( 1, 2.2 ). …
— FDA label: Herceptin, Genentech, Inc., effective May 29, 2026. Read the full label on DailyMed →
The FDA has 6 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
6 of 6 FDA labels for this medicine have a boxed warning.
Forms and how it is given
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Biocon Biologics Inc.2 products
- Amgen, Inc2 products
- Mylan Institutional LLC1 product
- Cephalon, Inc.1 product
- Pfizer Laboratories Div Pfizer Inc1 product
- Genentech, Inc.1 product
- Organon LLC1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA103792 HERCEPTIN | Genentech | September 25, 1998 | 26, latest May 18, 2026 2026: Labeling · 2024: Efficacy · 2020: Labeling |
| BLA761073 KANJINTI | Amgen Inc | June 13, 2019 | 2, latest December 19, 2024 2024: BIOSIMILAR · 2019: Supplement |
| BLA761074 OGIVRI | Mylan GmbH | December 1, 2017 | 4, latest November 13, 2024 2024: BIOSIMILAR · 2023: Labeling · 2019: Labeling |
| BLA761081 TRAZIMERA | Pfizer Inc | March 11, 2019 | 3, latest August 21, 2025 2025: Labeling · 2020: Labeling · 2020: Labeling |
| BLA761091 HERZUMA | Celltrion Inc | December 14, 2018 | 4, latest May 22, 2025 2025: Labeling · 2024: BIOSIMILAR · 2019: Manufacturing (CMC) |
| BLA761100 ONTRUZANT | Samsung Bioepis Co Ltd | January 18, 2019 | 4, latest April 15, 2026 2026: Labeling · 2025: Labeling · 2025: Bioequivalence |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1922509, 1922512, 2107053, 2107058, 2169359, 2169362, 2174804, 2174809, 2179753, 2179758 … (+10) |
|---|---|
| SPL set ID of the quoted label | 492dbdb2-077e-4064-bff3-372d6af0a7a2 |
| FDA labels (SPL) | 6 |
| FDA applications | BLA103792, BLA761073, BLA761074, BLA761081, BLA761091, BLA761100 |
| Active ingredients (FDA) | TRASTUZUMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Herceptin, Genentech, Inc., effective May 29, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →