Medicine
Inlexzo 225 mg transdermal system
Inlexzo 225 mg transdermal system is a prescription medicine containing Gemcitabine for intravesical use, marketed by Janssen Biotech, 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 in the original carton at 20°C to 25°C (68°F to 77°F), with excursions…
Key facts
- Active ingredient (INN)
- Gemcitabine
- Brand
- Inlexzo
- Strength
- 225 mg
- Dosage form
- Transdermal system
- Route
- Intravesical
- Packs
- 1 system
- Marketing authorisation holder
- Janssen Biotech
- Manufacturer
- Janssen Biotech
- Origin register
- US FDA, United States
- Storage
- Store in the original carton at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01BC05 Gemcitabine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 14 September 2025
- Identifiers
- RxCUI 2723386, 2723391DailyMed set ID 3aef8dbc-34d0-4150-89f0-3b16cf0fbfdbNDC 57894-225Application NDA219683
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 system in 1 box | 57894-225-01 | Janssen Biotech | 14 September 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 15 May 1996 | 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 Gemcitabine
Clinical summary
Gemcitabine is a nucleoside metabolic inhibitor indicated in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy, among other approved uses. MedsAcross supplies Gemcitabine 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 GemcitabineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Gemcitabine prescribing information (Hospira) · U.S. National Library of Medicine, DailyMed
Need Inlexzo 225 mg transdermal system 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.