Prescription medicine
Dacarbazine First approved as Dtic-Dome
Dacarbazine (Dtic-Dome) is a prescription medicine with an FDA approval on record since 1975. FDA's NDC Directory lists it from 3 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the dacarbazine FDA label on DailyMed (effective October 20, 2022, Fresenius Kabi USA, LLC); the NDA 17575 record on Drugs@FDA; every dacarbazine label on DailyMed.
Highlights of the record
FDA label of October 20, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
It is recommended that dacarbazine be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. 1. Hemopoietic depression is the most common toxicity with dacarbazine (see WARNINGS ). 2. Hepatic necrosis has been reported (see WARNINGS ). 3. Studies have demonstrated this agent to have a carcinogenic and teratogenic effect when used in animals. 4. In treatment of each patient, the physician must weigh carefully the possibility of achieving therapeutic benefit against the risk of toxicity.
Used for
From the label: indications and usageDacarbazine for Injection is indicated in the treatment of metastatic malignant melanoma.
Forms and strengths
- 200 mg
- 10 mg/ml
- 200 mg/20ml
Injection (powder) for solution; injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- May 27, 1975 Dtic-Dome, Bayer Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first August 28, 1986; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 3 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)
- 2 since 2014 0 Class I among all firms' recalls; latest June 12, 2019; 1 more by firms not listed as its makers
- FAERS reports
- 7,411 through July 30, 2026
What is dacarbazine used for?
From the label: indications and usageDacarbazine for Injection is indicated in the treatment of metastatic malignant melanoma. In addition, Dacarbazine for Injection is also indicated for Hodgkin’s disease as a second-line therapy when used in combination with other effective agents.
FDA pharmacologic class: Alkylating Drug.
Source: FDA drug label (Dacarbazine), Fresenius Kabi USA, LLC, effective October 20, 2022 (SPL set b6b97e41-5f15-498c-abfb-d8443ea4d216), via openFDA; the full label on DailyMed
Is there a generic for dacarbazine (Dtic-Dome)?
The FDA approved the first generic dacarbazine on August 28, 1986. 6 generic applications are approved; 3 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 dacarbazine from 3 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.
- 1975 earliest approval on file
- 1986 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has dacarbazine been recalled?
The FDA's Enforcement Report lists 3 recalls naming dacarbazine since 2014: 0 Class I (the most serious), 2 Class II, 1 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of dacarbazine and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 10, 2021 | Class II | Teva Pharmaceuticals USA not a listed maker | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility … |
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
| November 25, 2014 | Class III | Hospira Inc. | Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when stored per the labeled conditions. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the dacarbazine label say about other medicines?
The dacarbazine label names no other medicine on this site. The labels of 3 other medicines name dacarbazine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name dacarbazine
Source: FDA drug label (Dacarbazine), Fresenius Kabi USA, LLC, effective October 20, 2022 (SPL set b6b97e41-5f15-498c-abfb-d8443ea4d216), via openFDA; the full label on DailyMed
What do FAERS reports show for dacarbazine?
The FDA Adverse Event Reporting System holds 7,411 reports that list dacarbazine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,301 are coded as a death and 2,802 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 alkylating drugs
- the pharmacologic class, with prices and generics
- Dacarbazine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other