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  4. NDC Product Code: 80631-200 Nuvaxovid Covid-19 Vaccine, Adjuvanted

NDC 80631-200 Nuvaxovid Covid-19 Vaccine, Adjuvanted

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 80631-200?
  4. Nuvaxovid Covid-19 Vaccine, Adjuvanted Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

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

Get all the details for National Drug Code (NDC) 80631-200 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:
80631-200
Proprietary Name:
Nuvaxovid Covid-19 Vaccine, Adjuvanted
Product Type: [3]
Labeler Name: [5]
Novavax, Inc.
Labeler Code:
80631
Product Label ID:
1a20513c-d255-46d7-8e6b-294cec4b44f4
FDA Application Number: [6]
BLA125817
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
05-16-2025
End Marketing Date: [10]
08-26-2025
Listing Expiration Date: [11]
08-26-2025
Exclude Flag: [12]
D
Code Navigator:

Code Structure Chart

Product Details

What is NDC 80631-200?

The NDC code 80631-200 is assigned by the FDA to the product Nuvaxovid Covid-19 Vaccine, Adjuvanted which is product labeled by Novavax, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 80631-200-10 10 syringe, glass in 1 carton / .5 ml in 1 syringe, glass (80631-200-01). 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 Nuvaxovid Covid-19 Vaccine, Adjuvanted?

NUVAXOVID is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older.NUVAXOVID is also indicated for individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

Which are Nuvaxovid Covid-19 Vaccine, Adjuvanted UNII Codes?

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

Which are Nuvaxovid Covid-19 Vaccine, Adjuvanted 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 Nuvaxovid Covid-19 Vaccine, Adjuvanted?

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:
  • RxCUI: 2692309 - SARS-CoV-2 (COVID-19) vaccine, protein NVX-CoV2705 0.5 ML Prefilled Syringe, 12y+
  • RxCUI: 2692309 - 0.5 ML SARS-CoV-2 (COVID-19) vaccine, protein NVX-CoV2705 0.01 MG/ML Prefilled Syringe
  • RxCUI: 2714928 - NUVAXOVID 2024-2025 vaccine 0.5 ML Prefilled Syringe
  • RxCUI: 2714928 - 0.5 ML SARS-CoV-2 (COVID-19) vaccine, protein NVX-CoV2705 0.01 MG/ML Prefilled Syringe [Nuvaxovid 2024-2025]
  • RxCUI: 2714928 - Nuvaxovid 2024-2025 vaccine 0.5 ML Prefilled Syringe

* 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.

[10] 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.

[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".