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  5. NDC Package Code: 85766-058-01 Xofluza

NDC Package 85766-058-01 Xofluza

Baloxavir Marboxil Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
85766-058-01
Package Description:
1 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
85766-058
Proprietary Name:
Xofluza
Non-Proprietary Name:
Baloxavir Marboxil
Substance Name:
Baloxavir Marboxil
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.)
11-Digit NDC Billing Format:
85766005801
Product Type:
Human Prescription Drug
Labeler Name:
Sportpharm, Inc. Dba Sportpharm
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):
BALOXAVIR MARBOXIL 80 mg/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
NDA210854
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
10-24-2018
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.

Frequently Asked Questions

What is NDC 85766-058-01?

The NDC Packaged Code 85766-058-01 is assigned to a package of 1 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack of Xofluza, a human prescription drug labeled by Sportpharm, Inc. Dba Sportpharm. The product's dosage form is tablet, film coated and is administered via oral form.

Is NDC 85766-058 included in the NDC Directory?

Yes, Xofluza with product code 85766-058 is active and included in the NDC Directory. The product was first marketed by Sportpharm, Inc. Dba Sportpharm on October 24, 2018 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 11-digit format for NDC 85766-058-01?

The 11-digit format is 85766005801. 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
5-3-285766-058-015-4-285766-0058-01