Medicine
Cyclophosphamide 1000 mg/5 mL injection
Cyclophosphamide 1000 mg/5 mL injection is a generic prescription medicine for intravenous use, made by 5 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 the vials refrigerated at 2°C to 8°C (36°F to 46°F). Store diluted…
Key facts
- Active ingredient (INN)
- Cyclophosphamide
- Brand
- Sold under the generic name
- Strength
- 1000 mg/5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 5 mL and 2 more
- Manufacturers
- Dr. Reddy's LaboratoriesIndiaEugiaIndiaBaxter HealthcareBluePoint LaboratoriesNexus Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store the vials refrigerated at 2°C to 8°C (36°F to 46°F). Store diluted solutions of cyclophosphamide according to Table 1 Cyclophosphamide is a hazardous product.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01AA01 Cyclophosphamide
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 August 2021
- Identifiers
- RxCUI 2386859, 2568661, 2568663DailyMed set ID c961a1ac-6705-4756-9abc-9d84a6fcb5c8, 3c1eb470-0bba-457d-94e3-b9508f0d398a, a5818647-d840-e9d7-c7b8-6541b485e44e +2NDC 14789-126, 55150-271, 75907-190 +2Application ANDA216783, NDA210735, NDA212501 +1
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 carton / 5 mL in 1 vial | 75907-190-07 | Dr. Reddy's LaboratoriesIndia | 20 June 2024 |
| 1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 55150-271-99 | EugiaIndia | 20 November 2023 |
| 1 vial in 1 carton / 5 mL in 1 vial | 0338-9779-01 | Baxter Healthcare | 1 August 2024 |
| 1 vial, glass in 1 carton / 5 mL in 1 vial, glass | 14789-126-05 | Nexus Pharmaceuticals | 30 March 2026 |
| 1 vial in 1 carton / 5 mL in 1 vial | 68001-564-22 | BluePoint Laboratories | 10 April 2023 |
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 16 November 1959 | 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 Cyclophosphamide
Clinical summary
Cyclophosphamide is a prescription medicine indicated for treatment of malignant Diseases, among other approved uses. It is available as powder for injection, injection and capsules for intravenous and oral use. MedsAcross supplies Cyclophosphamide 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 CyclophosphamideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Cyclophosphamide prescribing information (Baxter Healthcare) · U.S. National Library of Medicine, DailyMed
Need Cyclophosphamide 1000 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.