Medicine
Cisplatin 50 mg/50 mL injection
Cisplatin 50 mg/50 mL 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Do not refrigerate. Store at 20° to 25°C (68° to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Cisplatin
- Brand
- Sold under the generic name
- Strength
- 50 mg/50 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 50 mL, 1 vial of 50 mL and 8 more
- Manufacturers
- Accord HealthcareIndiaGland PharmaIndiaBluePoint LaboratoriesApotexFosun PharmaFresenius KabiHikma PharmaceuticalsSagent PharmaceuticalsTeva Parenteral MedicinesWG Critical Care
- Origin register
- US FDA, United States
- Storage
- Do not refrigerate. Store at 20° to 25°C (68° to 77°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01XA01 Cisplatin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 June 2000
- Identifiers
- RxCUI 309311DailyMed set ID de6302d5-85f0-4116-a709-57826c2c84fe, 00396546-6a80-4b9f-a5f8-c22c1d1bb173, 8d170f6f-37d7-41ce-aae2-33307a6ef3ae +8NDC 63323-103, 25021-253, 60505-6279 +8Application ANDA074735, ANDA207323, ANDA218868 +4
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 |
|---|---|---|---|
| 50 mL in 1 vial | 16729-288-11 | Accord HealthcareIndia | 13 December 2016 |
| 1 vial in 1 carton / 50 mL in 1 vial | 68083-162-01 | Gland PharmaIndia | 3 April 2017 |
| 1 vial, multi-dose in 1 carton / 50 mL in 1 vial, multi-dose | 60505-6279-0 | Apotex | 13 September 2024 |
| 1 vial in 1 carton / 50 mL in 1 vial | 72266-252-01 | Fosun Pharma | 11 August 2023 |
| 1 vial in 1 carton / 50 mL in 1 vial | 63323-103-51 | Fresenius Kabi | 5 September 2000 |
| 1 vial, multi-dose in 1 carton / 50 mL in 1 vial, multi-dose | 0143-9504-01 | Hikma Pharmaceuticals | 7 November 2000 |
| 1 vial in 1 carton / 50 mL in 1 vial | 25021-253-50 | Sagent Pharmaceuticals | 1 July 2023 |
| 1 vial, multi-dose in 1 carton / 50 mL in 1 vial, multi-dose | 0703-5747-11 | Teva Parenteral Medicines | 1 June 2000 |
| 1 vial, multi-dose in 1 carton / 50 mL in 1 vial, multi-dose | 44567-509-01 | WG Critical Care | 13 January 2012 |
| 1 vial in 1 carton / 50 mL in 1 vial | 68001-283-27 | BluePoint Laboratories | 2 August 2016 |
| 1 vial in 1 carton / 50 mL in 1 vial | 68001-608-24 | BluePoint Laboratories | 1 January 2024 |
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 19 December 1978 | 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 Cisplatin 50 mg/50 mL injection.
Other strengths and forms of Cisplatin
Clinical summary
Cisplatin is a platinum-based drug indicated for the treatment of advanced testicular cancer, among other approved uses. It is available as injection and powder for injection for intravenous use. MedsAcross supplies Cisplatin 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 CisplatinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Cisplatin prescribing information (WG Critical Care) · U.S. National Library of Medicine, DailyMed
Need Cisplatin 50 mg/50 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.