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  5. NDC Package Code: 57894-225-01 Inlexzo

NDC Package 57894-225-01 Inlexzo

Gemcitabine Intravesical System Intravesical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
57894-225-01
Package Description:
1 SYSTEM in 1 BOX
Product Code:
57894-225
Proprietary Name:
Inlexzo
Non-Proprietary Name:
Gemcitabine Intravesical
Substance Name:
Gemcitabine
Usage Information:
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.
11-Digit NDC Billing Format:
57894022501
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Janssen Biotech, Inc
Dosage Form:
System -
Administration Route(s):
Intravesical - Administration within the bladder.
Active Ingredient(s):
GEMCITABINE 225 mg/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
NDA219683
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
09-14-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
57894-225-991 SYSTEM in 1 BOX

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 57894-225-01?

The NDC Packaged Code 57894-225-01 is assigned to a package of 1 system in 1 box of Inlexzo, a human prescription drug labeled by Janssen Biotech, Inc. The product's dosage form is system and is administered via intravesical form.

Is NDC 57894-225 included in the NDC Directory?

Yes, Inlexzo with product code 57894-225 is active and included in the NDC Directory. The product was first marketed by Janssen Biotech, Inc on September 14, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 57894-225-01?

The 11-digit format is 57894022501. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-257894-225-015-4-257894-0225-01