Active ingredient
Dacarbazine
4 finished FDA listings contain Dacarbazine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- DACARBAZINE
- Dosage forms
- Injection, Powder, For Solution, Injection, Powder, Lyophilized, For Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 3
- Strengths listed
- 10 mg/ml · 200 mg/1 · 200 mg/20ml
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 3098
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 075259 | MEITHEAL | 1998-08-27 | 1 |
| ANDA 075371 | FRESENIUS KABI USA | 1999-08-27 | 2 |
| ANDA 075812 | HIKMA | 2001-06-15 | 1 |
Official labeling on DailyMed
- DACARBAZINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 6 · 2025-09-29
- DACARBAZINE INJECTION, POWDER, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] · version 1 · 2024-04-23
- DACARBAZINE (DACARBAZINE) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] · version 4 · 2022-10-31
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.