Medicine
Oxaliplatin 100 mg/20 mL powder for injection
Oxaliplatin 100 mg/20 mL powder for injection is a generic prescription medicine for intravenous use, made by 2 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° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C.
Key facts
- Active ingredient (INN)
- Oxaliplatin
- Brand
- Sold under the generic name
- Strength
- 100 mg/20 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 10 mL, 20 mL, 1 vial and 1 more
- Manufacturers
- Gland PharmaIndiaQilu Pharmaceutical
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01XA03 Oxaliplatin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 11 May 2016
- Identifiers
- RxCUI 1736784, 1736786DailyMed set ID d6178bc6-9dae-413f-8f47-de75d576c5b8, e9e47f3c-9acc-44f5-b0bd-d26fe9d35d64NDC 68083-170, 67184-0502, 68083-171 +1Application ANDA207385, ANDA204616
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 |
|---|---|---|---|
| 10 mL in 1 vial | 68083-170-01 | Gland PharmaIndia | 29 May 2017 |
| 20 mL in 1 vial | 68083-171-01 | Gland PharmaIndia | 29 May 2017 |
| 1 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 67184-0501-1 | Qilu Pharmaceutical | 11 May 2016 |
| 1 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose | 67184-0502-1 | Qilu Pharmaceutical | 11 May 2016 |
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 9 August 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 Oxaliplatin
Clinical summary
Oxaliplatin is a platinum-based drug indicated for adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. It is available as injection and powder for injection for intravenous use. MedsAcross supplies Oxaliplatin 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 OxaliplatinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Oxaliplatin prescribing information (Gland Pharma) · U.S. National Library of Medicine, DailyMed
Need Oxaliplatin 100 mg/20 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.