Quick answers
- What is Dactinomycin used for?
- The FDA-approved label (Dactinomycin, Eugia US LLC, June 18, 2024) says: “Dactinomycin for injection is an actinomycin indicated for the treatment of: adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen. adult and pediatric patients with rhabdomyosarcoma, as part of a multiphase, combination chemotherapy regimen. adult and pediatric patients with Ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dactinomycin have a boxed warning?
- No. None of the 5 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Dactinomycin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dactinomycin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Dactinomycin?
- 4 companies list prescription products of Dactinomycin in the FDA NDC Directory, including Eugia US LLC, XGen Pharmaceuticals DJB, Inc. and Hisun Pharmaceuticals USA, Inc..
What Dactinomycin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Dactinomycin for injection is an actinomycin indicated for the treatment of: adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen. adult and pediatric patients with rhabdomyosarcoma, as part of a multiphase, combination chemotherapy regimen. adult and pediatric patients with Ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. …
— FDA label: Dactinomycin, Eugia US LLC, effective June 18, 2024. Read the full label on DailyMed →
The FDA has 5 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.
The label quoted above has no boxed warning.
0 of 5 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 5 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.
- Eugia US LLC2 products
- XGen Pharmaceuticals DJB, Inc.1 product
- Hisun Pharmaceuticals USA, Inc.1 product
- Meitheal Pharmaceuticals Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (4)
- ANDA203385Eugia Pharma · November 9, 2017
- ANDA203999Xgen Pharms · May 20, 2019
- ANDA207232Hisun Pharm Hangzhou · July 16, 2019
- ANDA213463Meitheal · November 13, 2020
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) | 239179 |
|---|---|
| SPL set ID of the quoted label | 5da55538-2602-4704-a9da-603c9f7ff7dc |
| FDA labels (SPL) | 5 |
| FDA applications | 4 ANDA |
| Active ingredients (FDA) | DACTINOMYCIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Dactinomycin, Eugia US LLC, effective June 18, 2024; 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 →