Active ingredient
Dactinomycin
5 finished FDA listings contain Dactinomycin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- DACTINOMYCIN
- Dosage forms
- Injection, Powder, Lyophilized, For Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 4
- Strengths listed
- .5 mg/1 · .5 mg/ml
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 3100
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 203385 | EUGIA PHARMA | 2017-11-09 | 2 |
| ANDA 203999 | XGEN PHARMS | 2019-05-20 | 1 |
| ANDA 207232 | HISUN PHARM HANGZHOU | 2019-07-16 | 1 |
| ANDA 213463 | MEITHEAL | 2020-11-13 | 1 |
Official labeling on DailyMed
- DACTINOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC] · version 2 · 2024-06-19
- DACTINOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HISUN PHARMACEUTICALS USA, INC.] · version 8 · 2024-06-19
- DACTINOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XGEN PHARMACEUTICALS DJB, INC.] · version 9 · 2024-05-30
- DACTINOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC] · version 2 · 2023-12-27
- DACTINOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] · version 3 · 2020-11-19
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.