Itovebi Tablet, Film Coated
NDC Package 50242-079-01

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

Itovebi (inavolisib) tablets is 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)]. This formulation utilizes a tablet, film coated delivery system. Marketed by Genentech, Inc., this product is identified by NDC 50242-079 and is authorized under FDA application NDA219249.

Identification & Billing

NDC Package Code
50242-079-01
Package Description
1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE
Product Code
50242-079
11-Digit Billing Format
50242007901
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Itovebi
Non-Proprietary Name
Inavolisib
Substance Name
Inavolisib
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)
INAVOLISIB 9 mg/1
Pharmacologic Class
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)].

Regulatory & Marketing

Labeler Name
Genentech, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA219249
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-14-2024
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 (50242-079). Click a package code to view its specific billing and regulatory data.

50242-079-08
1 BOTTLE in 1 CARTON / 28 TABLET, FILM COATED in 1 BOTTLE
50242-079-86
1 BOTTLE in 1 CARTON / 28 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 50242-079-01 identifies a specific commercial package of 1 bottle in 1 carton / 30 tablet, film coated in 1 bottle of Itovebi, a human prescription drug labeled by Genentech, Inc.. This tablet, film coated is formulated for oral use and contains inavolisib 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 Genentech, Inc. on October 14, 2024. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50242007901. 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)
50242-079-01
11-Digit CMS (5-4-2)
50242-0079-01

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