Medicine
Datroway 100 mg/5 mL powder for injection
Datroway 100 mg/5 mL powder for injection is a prescription medicine containing Datopotamab deruxtecan for intravenous use, marketed by Daiichi Sankyo, 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 vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original…
Key facts
- Active ingredient (INN)
- Datopotamab deruxtecan
- Brand
- Datroway
- Strength
- 100 mg/5 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial
- Marketing authorisation holder
- Daiichi Sankyo
- Manufacturer
- Daiichi Sankyo
- Origin register
- US FDA, United States
- Storage
- Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of reconstitution. Do not shake the reconstituted or diluted solution.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01FX35 Datopotamab deruxtecan
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 January 2025
- Identifiers
- RxCUI 2703040, 2703046DailyMed set ID 2950227c-6230-4ca4-a135-46e44d9424a0NDC 65597-801Application BLA761394
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 |
|---|---|---|---|
| 1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 65597-801-01 | Daiichi Sankyo | 17 January 2025 |
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
Datopotamab deruxtecan is a prescription medicine indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC), among other approved uses. MedsAcross supplies Datopotamab deruxtecan 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 Datopotamab deruxtecanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- DATROWAY prescribing information (Daiichi Sankyo) · U.S. National Library of Medicine, DailyMed
- Datroway: European public assessment report (EPAR) · European Medicines Agency
Need Datroway 100 mg/5 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.