Medicine
Cyclophosphamide 1 g/50 mL powder for injection
Cyclophosphamide 1 g/50 mL powder for injection is a generic prescription medicine for intravenous use, made by 4 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
Store vials at or below 25°C (77°F). During transport or storage of…
Key facts
- Active ingredient (INN)
- Cyclophosphamide
- Brand
- Sold under the generic name
- Strength
- 1 g/50 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial and 9 more
- Manufacturers
- Hainan Poly PharmHisun PharmaceuticalsSagent PharmaceuticalsSlate Run Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store vials at or below 25°C (77°F). During transport or storage of cyclophosphamide vials, temperature influences can lead to melting of the active ingredient, cyclophosphamide.
- Cold chain
- Not required on record
- 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
- 15 January 2024
- Identifiers
- RxCUI 1734917, 1734919, 1734921DailyMed set ID 6fde2705-a2d8-4d48-9618-b9d99d051373, 329b5a3a-c7b9-4b11-abf0-009719cdfb79, 5bad5bfc-12c0-46a2-8355-1028f108ecbf +1NDC 14335-471, 25021-247, 42658-035 +9Application ANDA218632, ANDA214529
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 | 14335-470-10 | Hainan Poly Pharm | 3 January 2025 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 14335-471-10 | Hainan Poly Pharm | 3 January 2025 |
| 1 vial, single-dose in 1 carton / 100 mL in 1 vial, single-dose | 14335-472-10 | Hainan Poly Pharm | 3 January 2025 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 42658-033-01 | Hisun Pharmaceuticals | 20 October 2026 |
| 1 vial, single-dose in 1 carton / 100 mL in 1 vial, single-dose | 42658-034-01 | Hisun Pharmaceuticals | 16 October 2026 |
| 1 vial, single-dose in 1 carton / 25 mL in 1 vial, single-dose | 42658-035-01 | Hisun Pharmaceuticals | 16 October 2026 |
| 1 vial in 1 carton / 25 mL in 1 vial | 25021-247-50 | Sagent Pharmaceuticals | 15 January 2024 |
| 1 vial in 1 carton / 50 mL in 1 vial | 25021-248-51 | Sagent Pharmaceuticals | 15 January 2024 |
| 1 vial in 1 carton / 100 mL in 1 vial | 25021-249-51 | Sagent Pharmaceuticals | 15 January 2024 |
| 1 vial, single-dose in 1 carton / 25 mL in 1 vial, single-dose | 70436-105-80 | Slate Run Pharmaceuticals | 26 March 2025 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 70436-106-80 | Slate Run Pharmaceuticals | 26 March 2025 |
| 1 vial, single-dose in 1 carton / 100 mL in 1 vial, single-dose | 70436-107-80 | Slate Run Pharmaceuticals | 26 March 2025 |
| 1 vial, single-dose in 1 carton / 25 mL in 1 vial, single-dose | 10019-935-01 | — | 21 May 2008 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 10019-936-01 | — | 21 May 2008 |
| 1 vial, single-dose in 1 carton / 100 mL in 1 vial, single-dose | 10019-937-01 | — | 21 May 2008 |
| 1 vial, single-dose in 1 carton / 25 mL in 1 vial, single-dose | 10019-938-01 | — | 21 May 2008 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 10019-939-01 | — | 21 May 2008 |
| 1 vial, single-dose in 1 carton / 100 mL in 1 vial, single-dose | 10019-942-01 | — | 21 May 2008 |
| 1 vial, single-dose in 1 carton / 25 mL in 1 vial, single-dose | 10019-943-01 | — | 21 May 2008 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 10019-944-01 | — | 21 May 2008 |
| 1 vial, single-dose in 1 carton / 100 mL in 1 vial, single-dose | 10019-945-01 | — | 21 May 2008 |
| 1 vial, single-dose in 1 carton / 25 mL in 1 vial, single-dose | 10019-955-01 | — | 21 May 2008 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 10019-956-01 | — | 21 May 2008 |
| 1 vial, single-dose in 1 carton / 100 mL in 1 vial, single-dose | 10019-957-01 | — | 21 May 2008 |
| 1 vial, single-dose in 1 carton / 25 mL in 1 vial, single-dose | 70121-1238-1 | — | 31 May 2018 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 70121-1239-1 | — | 31 May 2018 |
| 1 vial, single-dose in 1 carton / 100 mL in 1 vial, single-dose | 70121-1240-1 | — | 31 May 2018 |
| 1 vial, single-dose in 1 carton / 25 mL in 1 vial, single-dose | 83703-549-01 | — | 21 May 2008 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 83703-550-01 | — | 21 May 2008 |
| 1 vial, single-dose in 1 carton / 100 mL in 1 vial, single-dose | 83703-551-01 | — | 21 May 2008 |
| 1 vial, single-dose in 1 carton / 25 mL in 1 vial, single-dose | 42806-901-26 | — | 30 June 2024 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 42806-902-26 | — | 30 June 2024 |
| 1 vial, single-dose in 1 carton / 100 mL in 1 vial, single-dose | 42806-903-26 | — | 30 June 2024 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 65219-131-20 | — | 17 November 2023 |
| 1 vial, single-dose in 1 carton / 100 mL in 1 vial, single-dose | 65219-133-20 | — | 17 November 2023 |
| 1 vial, single-dose in 1 carton / 25 mL in 1 vial, single-dose | 65219-135-20 | — | 17 November 2023 |
| 1 vial, single-dose in 1 carton / 25 mL in 1 vial, single-dose | 0781-3233-94 | — | 31 October 2014 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 0781-3244-94 | — | 31 October 2014 |
| 1 vial, single-dose in 1 carton / 100 mL in 1 vial, single-dose | 0781-3255-94 | — | 31 October 2014 |
| 1 vial, single-dose in 1 carton / 25 mL in 1 vial, single-dose | 39822-0250-1 | — | 19 December 2023 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 39822-0255-1 | — | 19 December 2023 |
| 1 vial, single-dose in 1 carton / 100 mL in 1 vial, single-dose | 39822-0260-1 | — | 19 December 2023 |
| 1 vial, single-dose in 1 carton / 25 mL in 1 vial, single-dose | 68001-442-26 | — | 19 October 2020 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 68001-443-27 | — | 19 October 2020 |
| 1 vial, single-dose in 1 carton / 100 mL in 1 vial, single-dose | 68001-444-32 | — | 19 October 2020 |
| 1 vial, single-dose in 1 carton / 25 mL in 1 vial, single-dose | 68001-694-27 | — | 15 March 2026 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 68001-695-32 | — | 15 March 2026 |
| 1 vial, single-dose in 1 carton / 100 mL in 1 vial, single-dose | 68001-696-32 | — | 15 March 2026 |
| 1 vial, single-dose in 1 carton / 25 mL in 1 vial, single-dose | 83634-205-50 | — | 1 February 2026 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 83634-206-51 | — | 1 February 2026 |
| 1 vial, single-dose in 1 carton / 100 mL in 1 vial, single-dose | 83634-207-51 | — | 1 February 2026 |
| 1 vial, single-dose in 1 carton / 100 mL in 1 vial, single-dose | 72572-083-01 | — | 14 December 2022 |
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
Alternatives
Other makers and brands of Cyclophosphamide 1 g/50 mL powder for injection.
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 1 g/50 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.