Medicine
Dactinomycin 0.5 mg/mL powder for injection
Dactinomycin 0.5 mg/mL powder for injection is a generic prescription medicine for intravenous use, made by 3 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20º to 25ºC (68º to 77ºF),. Protect from light and humidity.
Key facts
- Active ingredient (INN)
- Dactinomycin
- Brand
- Sold under the generic name
- Strength
- 0.5 mg/mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial and 1 more
- Manufacturers
- EugiaIndiaMeitheal PharmaceuticalsXGen Pharmaceuticals DJB
- Origin register
- US FDA, United States
- Storage
- Store at 20º to 25ºC (68º to 77ºF),. Protect from light and humidity.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01DA01 Dactinomycin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 31 July 2019
- Identifiers
- RxCUI 239179DailyMed set ID 5da55538-2602-4704-a9da-603c9f7ff7dc, 2aaca42a-3b79-4151-a727-83253556a540, efe03d73-eb11-45ff-a3cb-09a540ed352f +1NDC 55150-928, 71288-129, 39822-2100 +1Application ANDA203385, ANDA213463, ANDA203999
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 55150-431-01 | EugiaIndia | 15 March 2021 |
| 1 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 55150-928-02 | EugiaIndia | 15 March 2021 |
| 1 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 71288-129-02 | Meitheal Pharmaceuticals | 13 November 2020 |
| 1 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 39822-2100-2 | XGen Pharmaceuticals DJB | 31 July 2019 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 10 December 1964 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Dactinomycin
Clinical summary
Dactinomycin is an actinomycin indicated for the treatment of adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen, among other approved uses. MedsAcross supplies Dactinomycin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about DactinomycinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- DACTINOMYCIN prescribing information (Eugia) · U.S. National Library of Medicine, DailyMed
Need Dactinomycin 0.5 mg/mL powder for injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.