Medicine
Zepzelca 0.5 mg/mL powder for injection
Zepzelca 0.5 mg/mL powder for injection is a prescription medicine containing Lurbinectedin for intravenous use, marketed by Jazz Pharmaceuticals, 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 refrigerated at 2°C to 8°C (36°F to 46°F).
Key facts
- Active ingredient (INN)
- Lurbinectedin
- Brand
- Zepzelca
- Strength
- 0.5 mg/mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 8 mL
- Marketing authorisation holder
- Jazz Pharmaceuticals
- Manufacturer
- Jazz Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store refrigerated at 2°C to 8°C (36°F to 46°F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01XX69 Lurbinectedin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 June 2020
- Identifiers
- RxCUI 2374733, 2374738DailyMed set ID 632bb50c-3bcb-4c85-9056-fc33410550aeNDC 68727-712Application NDA213702
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 8 mL in 1 vial, single-dose | 68727-712-01 | Jazz Pharmaceuticals | 15 June 2020 |
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.
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
Clinical summary
Lurbinectedin is an alkylating drug indicated in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, for the maintenance treatment of adult patients with extensive-stage small cell lung cancer, among other approved uses. MedsAcross supplies Lurbinectedin 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 LurbinectedinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ZEPZELCA prescribing information (Jazz Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Zepzelca: European public assessment report (EPAR) · European Medicines Agency
Need Zepzelca 0.5 mg/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.