Medicine
Valstar 200 mg/5 mL injection
Valstar 200 mg/5 mL injection is a prescription medicine containing Valrubicin for intravesical use, marketed by Endo, 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 under refrigeration at 2°-8°C (36°-46°F) in the carton. DO NOT…
Key facts
- Active ingredient (INN)
- Valrubicin
- Brand
- Valstar
- Strength
- 200 mg/5 mL
- Dosage form
- Injection
- Route
- Intravesical
- Packs
- 4 vials of 5 mL
- Marketing authorisation holder
- Endo
- Manufacturer
- Endo
- Origin register
- US FDA, United States
- Storage
- Store vials under refrigeration at 2°-8°C (36°-46°F) in the carton. DO NOT FREEZE.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01DB09 Valrubicin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 October 1998
- Identifiers
- RxCUI 262063, 313567DailyMed set ID e96f30a0-6662-11de-8f80-0002a5d5c51bNDC 67979-001Application NDA020892
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 |
|---|---|---|---|
| 4 vial in 1 carton / 5 mL in 1 vial | 67979-001-01 | Endo | 1 October 1998 |
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 25 September 1998 | 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 Valrubicin 200 mg/5 mL injection.
Clinical summary
Valrubicin is a prescription medicine indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. MedsAcross supplies Valrubicin 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 ValrubicinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Valstar prescribing information (Endo) · U.S. National Library of Medicine, DailyMed
Need Valstar 200 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.