Medicine
Mitoxantrone 25 mg/12.5 mL injection
Mitoxantrone 25 mg/12.5 mL 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
Keep from freezing. STORE AT: 20º to 25ºC (68° to 77°F).
Key facts
- Active ingredient (INN)
- Mitoxantrone
- Brand
- Sold under the generic name
- Strength
- 25 mg/12.5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 12.5 mL
- Manufacturers
- Fresenius KabiHospiraMeitheal Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Keep from freezing. STORE AT: 20º to 25ºC (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01DB07 Mitoxantrone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 11 April 2006
- Identifiers
- RxCUI 197989DailyMed set ID fcb8ef8a-f770-4416-8fc5-fa01d98c8eee, 1634528a-30c5-4309-acc8-4c0293ae14ae, accf9569-4b57-4e83-a7db-4e890a75d1baNDC 63323-132, 71288-179, 61703-343Application ANDA077496, ANDA077356, ANDA076871
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, multi-dose in 1 box / 12.5 mL in 1 vial, multi-dose | 63323-132-12 | Fresenius Kabi | 11 April 2006 |
| 1 vial, multi-dose in 1 carton / 12.5 mL in 1 vial, multi-dose | 61703-343-65 | Hospira | 11 April 2006 |
| 1 vial, multi-dose in 1 carton / 12.5 mL in 1 vial, multi-dose | 71288-179-13 | 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 23 December 1987 | 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 Mitoxantrone
Clinical summary
Mitoxantrone is a topoisomerase inhibitor indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients, among other approved uses. MedsAcross supplies Mitoxantrone 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 MitoxantroneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- mitoXANTRONE prescribing information (Meitheal Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Mitoxantrone 25 mg/12.5 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.