Prescription medicine
Dexrazoxane First approved as Zinecard
Dexrazoxane (Zinecard) is a prescription medicine with an FDA approval on record since 1995. FDA's NDC Directory lists it from 6 generic labelers.
- Generic listed
Check it at the source: the dexrazoxane FDA label on DailyMed (effective June 23, 2025, Gland Pharma Limited); the NDA 20212 record on Drugs@FDA; every dexrazoxane label on DailyMed.
Highlights of the record
FDA label of June 23, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageDexrazoxane 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.
Forms and strengths
- 250 mg
- 500 mg
- 250 mg/25ml
- 500 mg/50ml
Injection (powder) (lyophilized) for solution; kit.
On the market
- Earliest approval on file
- May 26, 1995 Zinecard, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first September 28, 2004; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 6 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 928 through July 30, 2026
What is dexrazoxane used for?
From the label: indications and usageDexrazoxane 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 [see Warnings and Precautions (5.2) ]. […]
FDA pharmacologic class: Cytoprotective Agent.
Source: FDA drug label (Dexrazoxane), Gland Pharma Limited, effective June 23, 2025 (SPL set c9c625fc-8852-4ed4-bcf2-63f46a706782), via openFDA; the full label on DailyMed
Is there a generic for dexrazoxane (Zinecard)?
The FDA approved the first generic dexrazoxane on September 28, 2004. 4 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists dexrazoxane from 6 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1995 earliest approval on file
- 2004 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the dexrazoxane label say about other medicines?
The dexrazoxane label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name dexrazoxane. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cyclophosphamide | warnings and precautions | In a trial conducted in patients with metastatic breast cancer who were treated with fluorouracil, doxorubicin, and cyclophosphamide (FAC) with or without dexrazoxane for injection starting with their first cycle of FAC therapy, patients who were randomized to receive dexrazoxane for injection had a lower response … |
| Doxorubicin | warnings and precautions | In a trial conducted in patients with metastatic breast cancer who were treated with fluorouracil, doxorubicin, and cyclophosphamide (FAC) with or without dexrazoxane for injection starting with their first cycle of FAC therapy, patients who were randomized to receive dexrazoxane for injection had a lower response … |
| Fluorouracil | warnings and precautions | In a trial conducted in patients with metastatic breast cancer who were treated with fluorouracil, doxorubicin, and cyclophosphamide (FAC) with or without dexrazoxane for injection starting with their first cycle of FAC therapy, patients who were randomized to receive dexrazoxane for injection had a lower response … |
Other labels that name dexrazoxane
Source: FDA drug label (Dexrazoxane), Gland Pharma Limited, effective June 23, 2025 (SPL set c9c625fc-8852-4ed4-bcf2-63f46a706782), via openFDA; the full label on DailyMed
What do FAERS reports show for dexrazoxane?
The FDA Adverse Event Reporting System holds 928 reports that list dexrazoxane among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 115 are coded as a death and 407 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other cytoprotective agents
- the pharmacologic class, with prices and generics
- Dexrazoxane side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other