Xofluza Granule, For Solution
NDC Package 50242-583-01

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

Package Information

Xofluza (baloxavir marboxil) granules is baloxavir marboxil is an antiviral medication used to treat the flu (influenza) if your symptoms started less than 48 hours ago. This formulation utilizes a granule, for solution delivery system. Marketed by Genentech, Inc., this product is identified by NDC 50242-583 and is authorized under FDA application NDA214410.

Identification & Billing

NDC Package Code
50242-583-01
Package Description
1 BOTTLE, GLASS in 1 CARTON / 20 mL in 1 BOTTLE, GLASS
Product Code
50242-583
11-Digit Billing Format
50242058301
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Xofluza
Non-Proprietary Name
Baloxavir Marboxil
Substance Name
Baloxavir Marboxil
Dosage Form
Granule, For Solution - A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BALOXAVIR MARBOXIL 40 mg/20mL
Pharmacologic Class
Usage Information
Baloxavir marboxil is an antiviral medication used to treat the flu (influenza) if your symptoms started less than 48 hours ago. It helps make the symptoms (such as stuffy nose, cough, sore throat, fever/chills, aches, tiredness) less severe and may shorten the recovery time by 1 to 2 days. Baloxavir marboxil works by stopping the flu virus from growing. It will not treat other kinds of infection besides the flu virus. Baloxavir marboxil is not a substitute for the flu vaccine. (See also Notes section.)

Regulatory & Marketing

Labeler Name
Genentech, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA214410
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-24-2018
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 50242-583-01 identifies a specific commercial package of 1 bottle, glass in 1 carton / 20 ml in 1 bottle, glass of Xofluza, a human prescription drug labeled by Genentech, Inc.. This granule, for solution is formulated for oral use and contains baloxavir marboxil 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 24, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Baloxavir marboxil is an antiviral medication used to treat the flu (influenza) if your symptoms started less than 48 hours ago. It helps make the symptoms (such as stuffy nose, cough, sore throat, fever/chills, aches, tiredness) less severe and may shorten the recovery time by 1 to 2 days. Baloxavir marboxil works by stopping the flu virus from growing. It will not treat other kinds of infection besides the flu virus. Baloxavir marboxil is not a substitute for the flu vaccine. (See also Notes section.)

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50242058301. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
50242-583-01
11-Digit CMS (5-4-2)
50242-0583-01

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