NDC Package 50242-091-86 Rozlytrek

Entrectinib Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

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:
50242-091-86
Package Description:
1 BOTTLE in 1 CARTON / 30 CAPSULE in 1 BOTTLE
Product Code:
Proprietary Name:
Rozlytrek
Non-Proprietary Name:
Entrectinib
Substance Name:
Entrectinib
Usage Information:
This medication is used to treat various types of cancer. Entrectinib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of cancer cells.
11-Digit NDC Billing Format:
50242009186
NDC to RxNorm Crosswalk:
  • RxCUI: 2197867 - entrectinib 100 MG Oral Capsule
  • RxCUI: 2197873 - ROZLYTREK 100 MG Oral Capsule
  • RxCUI: 2197873 - entrectinib 100 MG Oral Capsule [Rozlytrek]
  • RxCUI: 2197873 - Rozlytrek 100 MG Oral Capsule
  • RxCUI: 2197875 - entrectinib 200 MG Oral Capsule
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Genentech, Inc.
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    Yes
    FDA Application Number:
    NDA212725
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    08-15-2019
    Listing Expiration Date:
    12-31-2025
    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
    50242-091-301 BOTTLE in 1 CARTON / 30 CAPSULE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 50242-091-86?

    The NDC Packaged Code 50242-091-86 is assigned to a package of 1 bottle in 1 carton / 30 capsule in 1 bottle of Rozlytrek, a human prescription drug labeled by Genentech, Inc.. The product's dosage form is capsule and is administered via oral form.

    Is NDC 50242-091 included in the NDC Directory?

    Yes, Rozlytrek with product code 50242-091 is active and included in the NDC Directory. The product was first marketed by Genentech, Inc. on August 15, 2019 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 50242-091-86?

    The 11-digit format is 50242009186. 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
    5-3-250242-091-865-4-250242-0091-86