Novavax Covid-19 Vaccine, Adjuvanted
NDC 80631-100

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 80631-100?
  4. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Novavax Covid-19 Vaccine, Adjuvanted is a EMERGENCY USE AUTHORIZATION-approved product labeled by Novavax, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 80631-100 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
80631-100
Proprietary Name:
Novavax Covid-19 Vaccine, Adjuvanted
Product Type: [3]
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Novavax, Inc.
Labeler Code:
80631
Marketing Category: [8]
EMERGENCY USE AUTHORIZATION

Marketing Timeline

Start Marketing Date: [9]
01-31-2022
End Marketing Date: [10]
07-24-2024
Listing Expiration Date: [11]
07-24-2024
Exclude Flag: [12]
D

Code Structure Chart

Patient Education

COVID-19 Vaccine, Adjuvanted (Novavax)


What is COVID-19? COVID-19 disease is caused by a coronavirus called SARS-CoV-2. This type of coronavirus has not been seen before. You can get COVID-19 through contact with another person who has the virus. It is predominantly a respiratory (lung) illness that can affect other organs. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever, chills, cough, shortness of breath, fatigue, muscle or body aches, headache, loss of taste or smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhea.
[Learn More]


COVID-19 Vaccines


COVID-19 (coronavirus disease 2019) is an illness caused by a virus. This virus is a coronavirus called SARS-CoV-2. In the United States, there are several vaccines that are effective at protecting people from getting seriously ill, being hospitalized, and dying from COVID-19. Some of these vaccines have been approved by the U.S. Food and Drug Administration (FDA). Others are being used under Emergency Use Authorization (EUA) from the FDA. All of these vaccines have met the FDA's scientific standards for safety, effectiveness, and manufacturing quality needed to support authorization or approval.

This page includes details about the vaccines and the vaccination program, including where you can find a vaccine.

Centers for Disease Control and Prevention


[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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.
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".