Inlexzo System
NDC Package 57894-225-01
Package Information
Inlexzo (gemcitabine intravesical) systems is iNLEXZO is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ(CIS), with or without papillary tumors. This formulation utilizes a system delivery system. Marketed by Janssen Biotech, Inc, this product is identified by NDC 57894-225 and is authorized under FDA application NDA219683.
Identification & Billing
- RxCUI: 2723386 - gemcitabine 225 MG Intravesical System
- RxCUI: 2723386 - gemcitabine 225 MG Drug Implant
- RxCUI: 2723391 - inlexzo 225 MG Intravesical System
- RxCUI: 2723391 - gemcitabine 225 MG Drug Implant [Inlexzo]
- RxCUI: 2723391 - Inlexzo 225 MG Intravesical System
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 57894 - Janssen Biotech, Inc
- 57894-225 - Inlexzo
- 57894-225-01 - 1 SYSTEM in 1 BOX
- 57894-225 - Inlexzo
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
* Please review the full disclaimer at the bottom of this page.
Billing & HCPCS Mapping
To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.
Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.
* Please review the full disclaimer at the bottom of this page.
Other Available Packages
The following commercial packages are registered under the same Product NDC (57894-225). Click a package code to view its specific billing and regulatory data.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 57894-225-01 identifies a specific commercial package of 1 system in 1 box of Inlexzo, a human prescription drug labeled by Janssen Biotech, Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This system is formulated for intravesical use and contains gemcitabine as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Janssen Biotech, Inc on September 14, 2025. The current certification is valid through December 31, 2026.
How is this Janssen Biotech, Inc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 57894022501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
