Medicine
Vinorelbine 50 mg/5 mL injection
Vinorelbine 50 mg/5 mL 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. 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 under refrigeration at 2° to 8°C (36° to 46°F) in the carton…
Key facts
- Active ingredient (INN)
- Vinorelbine
- Brand
- Sold under the generic name
- Strength
- 50 mg/5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 5 mL
- Manufacturers
- Actavis PharmaSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store the vials under refrigeration at 2° to 8°C (36° to 46°F) in the carton. DO NOT FREEZE. Unopened vials of Vinorelbine Injection, USP are stable at 25°C (77°F) for up to 72 hours. Protect from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01CA04 Vinorelbine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 September 2014
- Identifiers
- RxCUI 1729418, 1729422DailyMed set ID dd3dcc9a-e40c-4677-9ee6-f318e7c7d835, 10a70995-e04d-4044-b1dc-c9aa27460397NDC 45963-607, 25021-204Application ANDA078011, ANDA091106
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 / 5 mL in 1 vial, single-dose | 45963-607-56 | Actavis Pharma | 1 March 2015 |
| 1 vial in 1 carton / 5 mL in 1 vial | 25021-204-05 | Sagent Pharmaceuticals | 15 September 2014 |
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 23 December 1994 | 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 Vinorelbine
Clinical summary
Vinorelbine is a vinca alkaloid. It is available as injection for intravenous use. MedsAcross supplies Vinorelbine 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 VinorelbineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Vinorelbine prescribing information (Sagent Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Vinorelbine 50 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.