United States · FDA National Drug Code directory

INLEXZO

A source-listed medicine record.

Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.

Medicine identity

Source reference
57894-225_3e9075cb-001f-40f0-e063-6394a90aee94
Product NDC
57894-225
Form
SYSTEM
Composition / generic term
gemcitabine intravesical
Labeler
Janssen Biotech, Inc
Marketing category
NDA
Marketing start / end (source format)
20250914
Source listing expiry
20261231

Source-listed ingredients

  • GEMCITABINE — 225 mg/1

These values do not establish equivalence or a dose recommendation.

Packages

  • 1 SYSTEM in 1 BOX (57894-225-01) · 57894-225-01
  • 1 SYSTEM in 1 BOX (57894-225-99) · 57894-225-99

Source and coverage

Open FDA National Drug Code directory

Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.

Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.

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