# INLEXZO

NDC: 57894-225
Generic name: gemcitabine intravesical
Labeler / Manufacturer: Janssen Biotech, Inc
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: New Drug Application (innovator)
Dosage form: SYSTEM
Routes: INTRAVESICAL
Marketing started: 20250914

FDA application: NDA219683

## Active ingredients

- GEMCITABINE: 225 mg/1

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"57894-225"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=57894-225
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3aef8dbc-34d0-4150-89f0-3b16cf0fbfdb