Quick answers
- What is Dacarbazine used for?
- The FDA-approved label (Dacarbazine, Hikma Pharmaceuticals USA Inc., September 22, 2025) says: “Dacarbazine for Injection, USP is indicated in the treatment of metastatic malignant melanoma. In addition, dacarbazine is also indicated for Hodgkin's disease as a second-line therapy when used in combination with other effective agents.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dacarbazine have a boxed warning?
- Yes. The FDA label for Dacarbazine has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Dacarbazine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dacarbazine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Dacarbazine?
- 3 companies list prescription products of Dacarbazine in the FDA NDC Directory, including Fresenius Kabi USA, LLC, Meitheal Pharmaceuticals Inc. and Hikma Pharmaceuticals USA Inc..
What Dacarbazine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Dacarbazine for Injection, USP is indicated in the treatment of metastatic malignant melanoma. In addition, dacarbazine is also indicated for Hodgkin's disease as a second-line therapy when used in combination with other effective agents.
— FDA label: Dacarbazine, Hikma Pharmaceuticals USA Inc., effective September 22, 2025. Read the full label on DailyMed →
The FDA has 3 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.
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 →
3 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, for solution · Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 4 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.
- Fresenius Kabi USA, LLC2 products
- Meitheal Pharmaceuticals Inc.1 product
- Hikma Pharmaceuticals USA Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (3)
- ANDA075259Meitheal · August 27, 1998
- ANDA075371Fresenius Kabi USA · August 27, 1999
- ANDA075812Hikma · June 15, 2001
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) | 1731338, 1731340 |
|---|---|
| SPL set ID of the quoted label | 0d81315c-7021-4091-b703-ad135390c936 |
| FDA labels (SPL) | 3 |
| FDA applications | 3 ANDA |
| Active ingredients (FDA) | DACARBAZINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Dacarbazine, Hikma Pharmaceuticals USA Inc., effective September 22, 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 →