Medicine
Mitomycin 5 mg/10 mL powder for injection
Mitomycin 5 mg/10 mL powder for injection is a generic prescription medicine for intravenous use, made by 10 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 solution under refrigeration 2° to 8°C (36° to 46°F), discard after 14…
Key facts
- Active ingredient (INN)
- Mitomycin
- Brand
- Sold under the generic name
- Strength
- 5 mg/10 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial and 26 more
- Manufacturers
- Accord HealthcareIndiaEugiaIndiaGland PharmaIndiaArchis PharmaBluePoint LaboratoriesFresenius KabiMeitheal PharmaceuticalsSagent PharmaceuticalsBryant Ranch PrepackHikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store solution under refrigeration 2° to 8°C (36° to 46°F), discard after 14 days. Store dry powder at 20° to 25°C (68° to 77°F), protected from light. Avoid excessive heat, over 40°C (104°F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 May 1996
- Identifiers
- RxCUI 1740894, 1740898, 1740900DailyMed set ID 5f41676f-f687-47db-871c-35bbf2447a98, f5a010cf-5954-4e6d-acfa-fb414efdf471, bc937e3d-7167-49a5-b6b1-004b0f89d8c4 +13NDC 71335-2927, 55150-451, 65219-568 +25Application ANDA202670, ANDA216732, ANDA216648 +6
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 in 1 box, unit-dose / 40 mL in 1 vial | 16729-108-11 | Accord HealthcareIndia | 10 June 2009 |
| 1 vial in 1 carton / 10 mL in 1 vial | 16729-115-05 | Accord HealthcareIndia | 18 June 2009 |
| 1 vial in 1 box, unit-dose / 80 mL in 1 vial | 16729-116-38 | Accord HealthcareIndia | 11 March 2011 |
| 1 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 55150-450-01 | EugiaIndia | 30 October 2023 |
| 1 vial, single-dose in 1 carton / 40 mL in 1 vial, single-dose | 55150-451-01 | EugiaIndia | 30 October 2023 |
| 1 vial, single-dose in 1 carton / 80 mL in 1 vial, single-dose | 55150-452-01 | EugiaIndia | 30 October 2023 |
| 1 vial in 1 carton / 10 mL in 1 vial | 68083-483-01 | Gland PharmaIndia | 20 October 2021 |
| 1 vial in 1 carton / 40 mL in 1 vial | 68083-484-01 | Gland PharmaIndia | 20 October 2021 |
| 1 vial, single-dose in 1 carton / 80 mL in 1 vial, single-dose | 68083-502-01 | Gland PharmaIndia | 22 November 2022 |
| 1 vial in 1 carton / 10 mL in 1 vial | 72819-152-05 | Archis Pharma | 25 April 2022 |
| 1 vial in 1 carton / 10 mL in 1 vial | 72819-152-95 | Archis Pharma | 11 March 2022 |
| 1 vial in 1 carton / 40 mL in 1 vial | 72819-153-02 | Archis Pharma | 25 April 2022 |
| 1 vial in 1 carton / 80 mL in 1 vial | 72819-154-04 | Archis Pharma | 25 April 2022 |
| 1 vial in 1 carton / 10 mL in 1 vial | 65219-564-20 | Fresenius Kabi | 15 January 2023 |
| 1 vial in 1 carton / 40 mL in 1 vial | 65219-566-20 | Fresenius Kabi | 15 January 2023 |
| 1 vial, single-dose in 1 carton / 80 mL in 1 vial, single-dose | 65219-568-00 | Fresenius Kabi | 15 January 2023 |
| 1 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 71288-137-20 | Meitheal Pharmaceuticals | 8 September 2022 |
| 1 vial, single-dose in 1 carton / 40 mL in 1 vial, single-dose | 71288-138-50 | Meitheal Pharmaceuticals | 8 September 2022 |
| 1 vial, single-dose in 1 carton / 80 mL in 1 vial, single-dose | 71288-139-51 | Meitheal Pharmaceuticals | 6 September 2022 |
| 1 vial in 1 carton / 10 mL in 1 vial | 25021-250-20 | Sagent Pharmaceuticals | 15 June 2023 |
| 1 vial in 1 carton / 40 mL in 1 vial | 25021-251-50 | Sagent Pharmaceuticals | 15 June 2023 |
| 1 vial in 1 carton / 80 mL in 1 vial | 25021-252-51 | Sagent Pharmaceuticals | 15 June 2023 |
| 1 vial in 1 box, unit-dose / 40 mL in 1 vial | 0143-9279-01 | Hikma Pharmaceuticals | 1 May 1996 |
| 1 vial in 1 box, unit-dose / 80 mL in 1 vial | 0143-9280-01 | Hikma Pharmaceuticals | 1 September 1999 |
| 1 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 68001-615-36 | BluePoint Laboratories | 8 July 2024 |
| 1 vial, single-dose in 1 carton / 40 mL in 1 vial, single-dose | 68001-616-77 | BluePoint Laboratories | 24 June 2024 |
| 1 vial, single-dose in 1 carton / 80 mL in 1 vial, single-dose | 68001-617-79 | BluePoint Laboratories | 11 July 2024 |
| 1 vial in 1 carton / 10 mL in 1 vial | 71335-2927-1 | Bryant Ranch Prepack | 11 November 2025 |
| 1 vial in 1 carton / 10 mL in 1 vial | 72162-2464-2 | Bryant Ranch Prepack | 6 March 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 14 November 2002 | 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 Mitomycin
Clinical summary
Mitomycin is an alkylating drug indicated as an adjunct to ab externo glaucoma surgery. It is available as powder for injection and kits for intravenous use. MedsAcross supplies Mitomycin 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 MitomycinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Mitosol prescribing information (Mobius Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Mitomycin 5 mg/10 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.