Medicine
Doxorubicin 50 mg/25 mL injection
Doxorubicin 50 mg/25 mL injection is a generic prescription medicine for intravenous use, made by 7 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 refrigerated between 2° and 8°C (36° and 46°F). Storage of Doxorubicin…
Key facts
- Active ingredient (INN)
- Doxorubicin
- Brand
- Sold under the generic name
- Strength
- 50 mg/25 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 25 mL and 6 more
- Manufacturers
- Gland PharmaIndiaSun Pharmaceutical IndustriesIndiaHikma PharmaceuticalsPfizer LaboratoriesActavis PharmaFresenius KabiSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store refrigerated between 2° and 8°C (36° and 46°F). Storage of Doxorubicin Hydrochloride Injection, USP under refrigerated conditions can result in the formation of a gelled product. Place gelled product at room temperature [15º to 30ºC (59º to 86ºF)] for 2 to 4 hours to return the product to a slightly viscous, mobile solution. Protect from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01DB01 Doxorubicin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 May 1996
- Identifiers
- RxCUI 1191138, 1790100, 1790097 +2DailyMed set ID ae80bd3a-b99a-4e01-a444-b9d05687f00e, e0349f98-42fa-4003-b6d8-a1db1401b0ef, 36924f82-6c05-4989-9f41-a398c0ad48e6 +6NDC 25021-207, 63323-883, 0143-9086 +6Application ANDA209825, ANDA063277, ANDA062975 +3
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 / 25 mL in 1 vial, single-dose | 68083-249-01 | Gland PharmaIndia | 22 August 2017 |
| 1 vial, single-dose in 1 box / 25 mL in 1 vial, single-dose | 62756-826-40 | Sun Pharmaceutical IndustriesIndia | 20 February 2012 |
| 1 vial in 1 box / 25 mL in 1 vial | 0143-9086-01 | Hikma Pharmaceuticals | 1 May 1996 |
| 1 vial in 1 box / 25 mL in 1 vial | 0143-9090-01 | Hikma Pharmaceuticals | 1 October 2019 |
| 1 vial, single-dose in 1 carton / 25 mL in 1 vial, single-dose | 0069-0343-02 | Pfizer Laboratories | 11 November 2024 |
| 1 vial, single-dose in 1 carton / 25 mL in 1 vial, single-dose | 0069-3358-25 | Pfizer Laboratories | 11 November 2024 |
| 1 vial, single-dose in 1 carton / 25 mL in 1 vial, single-dose | 45963-733-68 | Actavis Pharma | 1 November 2014 |
| 1 vial, single-dose in 1 carton / 25 mL in 1 vial, single-dose | 63323-883-30 | Fresenius Kabi | 14 April 2000 |
| 1 vial in 1 carton / 25 mL in 1 vial | 25021-207-25 | Sagent Pharmaceuticals | 31 October 2013 |
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.
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 Doxorubicin
Clinical summary
Doxorubicin is an anthracycline topoisomerase inhibitor indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer, among other approved uses. MedsAcross supplies Doxorubicin 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 DoxorubicinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Doxorubicin Hydrochloride prescribing information (Pfizer Laboratories) · U.S. National Library of Medicine, DailyMed
- Caelyx pegylated liposomal: European public assessment report (EPAR) · European Medicines Agency
- Myocet liposomal (previously Myocet): European public assessment report (EPAR) · European Medicines Agency
Need Doxorubicin 50 mg/25 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.