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  5. NDC Package Code: 50242-079-08 Itovebi

NDC Package 50242-079-08 Itovebi

Inavolisib Tablet, Film Coated Oral - 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:
50242-079-08
Package Description:
1 BOTTLE in 1 CARTON / 28 TABLET, FILM COATED in 1 BOTTLE
Product Code:
50242-079
Proprietary Name:
Itovebi
Non-Proprietary Name:
Inavolisib
Substance Name:
Inavolisib
Usage Information:
ITOVEBI, in combination with palbociclib and fulvestrant, is indicated for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy [see Clinical Studies (14.1)].
11-Digit NDC Billing Format:
50242007908
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Genentech, Inc.
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
INAVOLISIB 9 mg/1
Sample Package:
No
FDA Application Number:
NDA219249
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
10-14-2024
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
50242-079-011 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE
50242-079-861 BOTTLE in 1 CARTON / 28 TABLET, FILM COATED in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 50242-079-08?

The NDC Packaged Code 50242-079-08 is assigned to a package of 1 bottle in 1 carton / 28 tablet, film coated in 1 bottle of Itovebi, a human prescription drug labeled by Genentech, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

Is NDC 50242-079 included in the NDC Directory?

Yes, Itovebi with product code 50242-079 is active and included in the NDC Directory. The product was first marketed by Genentech, Inc. on October 14, 2024 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 NDC billing unit for package 50242-079-08?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

What is the 11-digit format for NDC 50242-079-08?

The 11-digit format is 50242007908. 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
5-3-250242-079-085-4-250242-0079-08