Medicine
Idarubicin 5 mg/5 mL injection
Idarubicin 5 mg/5 mL injection is a generic prescription medicine for intravenous use, made by 2 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store under refrigeration 2° to 8°C (36° to 46°F), and protect from light.
Key facts
- Active ingredient (INN)
- Idarubicin
- Brand
- Sold under the generic name
- Strength
- 5 mg/5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 5 mL
- Manufacturers
- Hikma PharmaceuticalsMeitheal Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store under refrigeration 2° to 8°C (36° to 46°F), and protect from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01DB06 Idarubicin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 January 2017
- Identifiers
- RxCUI 1791493, 1791498, 1791500DailyMed set ID 7c20b574-285b-49eb-a98e-6752e4bb481d, d31254be-6bd2-4ac1-acab-bc00e2209d28, b9b337d5-50f7-4ea9-9df4-72c86e4c0b91NDC 0143-9306, 71288-184, 0143-9217Application ANDA065275, ANDA065036
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, glass in 1 box / 5 mL in 1 vial, glass | 0143-9217-01 | Hikma Pharmaceuticals | 30 January 2017 |
| 1 vial, glass in 1 box / 5 mL in 1 vial, glass | 0143-9306-01 | Hikma Pharmaceuticals | 12 January 2018 |
| 1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 71288-184-05 | Meitheal Pharmaceuticals | 1 June 2025 |
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 27 September 1990 | 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
Alternatives
Other makers and brands of Idarubicin 5 mg/5 mL injection.
Other strengths and forms of Idarubicin
Clinical summary
Idarubicin is an anthracycline topoisomerase inhibitor indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen. It is available as injection for intravenous use. MedsAcross supplies Idarubicin 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 IdarubicinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Idamycin PFS prescribing information (Pfizer Laboratories) · U.S. National Library of Medicine, DailyMed
Need Idarubicin 5 mg/5 mL 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.