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  4. NDC Product Code: 50090-4104 Xofluza

NDC 50090-4104 Xofluza

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 50090-4104?
  5. Xofluza Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Get all the details for National Drug Code (NDC) 50090-4104 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
50090-4104
Proprietary Name:
Xofluza
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
A-s Medication Solutions
Labeler Code:
50090
Product Label ID:
325b077a-8fe2-435c-be70-df9579862e13
FDA Application Number: [6]
NDA210854
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
10-24-2018
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330 - WHITE TO LIGHT YELLOW)
Shape:
OVAL (C48345)
Size(s):
11 MM
Imprint(s):
BXM40
Score:
1

Code Structure Chart

Product Details

What is NDC 50090-4104?

The NDC code 50090-4104 is assigned by the FDA to the product Xofluza which is product labeled by A-s Medication Solutions. The product's dosage form is . The product is distributed in a single package with assigned NDC code 50090-4104-0 1 blister pack in 1 carton / 2 tablet, film coated in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Xofluza?

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.)

Which are Xofluza UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Xofluza Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Xofluza?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

* Please review the disclaimer below.

Patient Education

Baloxavir Marboxil


Baloxavir marboxil is used to treat some types of influenza infection ('flu') in adults and children 5 years and older who have had symptoms of the flu for no longer than 2 days and who are otherwise healthy or are at high risk for developing influenza-related complications. Baloxavir marboxil is also used to treat some types of flu in adults and children 12 years and older who have had symptoms of the flu for no longer than 2 days and who are at high risk for developing influenza-related complications. It is also used to prevent some types of flu in adults and children 5 years and older when they have spent time with someone who has the flu. Baloxavir marboxil is in a class of medications called polymerase acidic endonuclease inhibitors. It works by stopping the spread of the flu virus in the body. Baloxavir marboxil helps to shorten the time that flu symptoms such as a stuffy or runny nose, sore throat, cough, muscle or joint aches, tiredness, headache, fever, and chills last. Baloxavir marboxil will not prevent bacterial infections, which may occur as a complication of the flu.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".