Quick answers
- What is Dexrazoxane for injection used for?
- The FDA-approved label (Dexrazoxane, Almaject, Inc., August 1, 2025) says: “Dexrazoxane for Injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m 2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use with the initiation of doxorubicin therapy […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dexrazoxane for injection have a boxed warning?
- No. None of the 6 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Dexrazoxane for injection?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dexrazoxane for injection been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Dexrazoxane for injection?
- 5 companies list prescription products of Dexrazoxane for injection in the FDA NDC Directory, including Hikma Pharmaceuticals USA Inc., Almaject, Inc. and Fosun Pharma USA Inc..
What Dexrazoxane for injection is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Dexrazoxane for Injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m 2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use with the initiation of doxorubicin therapy […]. …
— FDA label: Dexrazoxane, Almaject, Inc., effective August 1, 2025. 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.
The label quoted above has no boxed warning.
0 of 6 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 9 in the FDA NDC Directory |
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.
- Hikma Pharmaceuticals USA Inc.2 products
- Almaject, Inc.2 products
- Fosun Pharma USA Inc.2 products
- Gland Pharma Limited2 products
- Novadoz Pharmaceuticals LLC2 products
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (3)
- ANDA076068Hikma · September 28, 2004
- ANDA207321Gland · November 28, 2016
- ANDA216748Msn · March 26, 2025
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) | 1736585, 1736590 |
|---|---|
| SPL set ID of the quoted label | 9cbd2987-10bb-eceb-153d-ee7be1ed0c84 |
| FDA labels (SPL) | 6 |
| FDA applications | 3 ANDA |
| Active ingredients (FDA) | DEXRAZOXANE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Dexrazoxane, Almaject, Inc., effective August 1, 2025; 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 →