Lazcluze Tablet, Film Coated
NDC Package 57894-080-90

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Lazcluze (lazertinib) tablets is lAZCLUZE, in combination with amivantamab, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1)]. This formulation utilizes a tablet, film coated delivery system. Marketed by Janssen Biotech, Inc., this product is identified by NDC 57894-080 and is authorized under FDA application NDA219008.

Identification & Billing

NDC Package Code
57894-080-90
Package Description
1 BOTTLE in 1 CARTON / 90 TABLET, FILM COATED in 1 BOTTLE
Product Code
57894-080
11-Digit Billing Format
57894008090
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lazcluze
Non-Proprietary Name
Lazertinib
Substance Name
Lazertinib
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LAZERTINIB 80 mg/1
Pharmacologic Class
Usage Information
LAZCLUZE, in combination with amivantamab, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1)] .

Regulatory & Marketing

Labeler Name
Janssen Biotech, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA219008
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-20-2024
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (57894-080). Click a package code to view its specific billing and regulatory data.

57894-080-60
1 BOTTLE in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE

* 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 57894-080-90 identifies a specific commercial package of 1 bottle in 1 carton / 90 tablet, film coated in 1 bottle of Lazcluze, a human prescription drug labeled by Janssen Biotech, Inc.. This tablet, film coated is formulated for oral use and contains lazertinib 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 August 20, 2024. The current certification is valid through December 31, 2027.

How is this Janssen Biotech, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57894008090. 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:

10-Digit Format (5-3-2)
57894-080-90
11-Digit CMS (5-4-2)
57894-0080-90

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.