Medicine
Cyclophosphamide 50 mg capsule
Cyclophosphamide 50 mg capsule is a generic prescription medicine for oral 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15ºC…
Key facts
- Active ingredient (INN)
- Cyclophosphamide
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules and 3 more
- Manufacturers
- Alembic PharmaceuticalsIndiaCiplaIndiaAmneal PharmaceuticalsHikma PharmaceuticalsOPKO Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15ºC to 30ºC (59°F to 86°F).
- 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
- 16 September 2013
- Identifiers
- RxCUI 1437968, 1437969DailyMed set ID 8135b917-882f-4b4c-99b7-fa8ea54af4bf, 9e699cf7-860e-4c03-9760-0c24d56df2de, 0e1cb955-99c8-4fe5-89d1-399c8e52174e +3NDC 0054-0383, 46708-619, 69097-517 +3Application NDA203856, ANDA215892, ANDA211608 +2
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 |
|---|---|---|---|
| 100 capsule in 1 bottle | 46708-619-31 | Alembic PharmaceuticalsIndia | 23 November 2022 |
| 100 capsule in 1 bottle | 62332-619-31 | Alembic PharmaceuticalsIndia | 23 November 2022 |
| 100 capsule in 1 bottle | 69097-517-07 | CiplaIndia | 18 January 2019 |
| 100 capsule in 1 bottle | 69238-1562-1 | Amneal Pharmaceuticals | 3 November 2026 |
| 100 capsule in 1 bottle | 0054-0383-25 | Hikma Pharmaceuticals | 16 September 2013 |
| 100 capsule in 1 bottle | 70301-2015-1 | OPKO Pharmaceuticals | 16 September 2026 |
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 50 mg capsule 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.