The short version
Only one company currently supplies this market — there is no backup if it stumbles.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Inlexzo
gemcitabine intravesical · GEMCITABINE 225 mg/1 · System · Intravesical · Janssen Biotech, Inc
NDC 57894-0225-99 · 1 SYSTEM in 1 BOX · NDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- Alcami Carolinas CorporationUnited Statesanalysis
- AndersonBrecon Inc.United Statespack
- analysis · manufacture
- Catalent CTS, LLCUnited Statesanalysis · manufacture · pack
- Corden Pharma GmbHGermanyanalysis · manufacture · pack
- Eurofins Biolab SrlItalyanalysis
- Isomedix Operations Inc.United Statessterilize
- Janssen Pharmaceutica NVBelgiumanalysis · pack
- analysis
- Labor LS SE & Co. KGGermanyanalysis
- NACS, Inc.United Statesmanufacture
- analysis · api manufacture
- analysis
- Sterigenics U.S., LLCUnited Statessterilize
- Sterigenics U.S., LLCUnited Statessterilize
- Steris LaboratoriesUnited Statessterilize
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- NDA219683
- TE code
- —
- Approval date
- Sep 9, 2025
- Patents / exclusivity
- 6 patents, 1 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | NP | Sep 9, 2028 |
| patent | 12636300 | Nov 7, 2038 |
| patent | 10729823 | Aug 19, 2034 |
| patent | 12447241 | Aug 19, 2034 |
| patent | 8679094 | Apr 15, 2032 |
| patent | 12576253 | Dec 17, 2030 |
| patent | 12403086 | Jun 28, 2030 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of gemcitabine intravesical (System)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Janssen Biotech, Inc | GEMCITABINE 225 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Inlexzo — NDC 57894-0225-99," retrieved September 3, 2026, https://drugdashboards.com/drug/57894022599.
Free to cite with attribution — see how the data is put together.