Zelboraf Tablet, Film Coated
NDC Package 50242-090-02

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

Package Information

Zelboraf (vemurafenib) tablets is vemurafenib is used to treat a type of skin cancer (melanoma). This formulation utilizes a tablet, film coated delivery system. Marketed by Genentech, Inc., this product is identified by NDC 50242-090 and is authorized under FDA application NDA202429.

Identification & Billing

NDC Package Code
50242-090-02
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 112 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
50242-090
11-Digit Billing Format
50242009002
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zelboraf
Non-Proprietary Name
Vemurafenib
Substance Name
Vemurafenib
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)
VEMURAFENIB 240 mg/1
Pharmacologic Class
Usage Information
Vemurafenib is used to treat a type of skin cancer (melanoma). It is also used to treat a rare type of blood cell cancer called Erdheim-Chester disease. These cancer cells have a certain type of abnormal "BRAF" gene. Vemurafenib works by slowing the growth of certain cancer cells. It belongs to a class of drugs known as kinase inhibitors.

Regulatory & Marketing

Labeler Name
Genentech, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA202429
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-17-2011
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50242-090-02 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 112 tablet, film coated in 1 bottle, plastic of Zelboraf, a human prescription drug labeled by Genentech, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This tablet, film coated is formulated for oral use and contains vemurafenib 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 August 17, 2011. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Vemurafenib is used to treat a type of skin cancer (melanoma). It is also used to treat a rare type of blood cell cancer called Erdheim-Chester disease. These cancer cells have a certain type of abnormal "BRAF" gene. Vemurafenib works by slowing the growth of certain cancer cells. It belongs to a class of drugs known as kinase inhibitors.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50242009002. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
50242-090-02
11-Digit CMS (5-4-2)
50242-0090-02

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