Nuvaxovid Covid-19 Vaccine, Adjuvanted
NDC Package 80631-200-10

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

Package Information

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

Nuvaxovid Covid-19 Vaccine, Adjuvanted is 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. Marketed by Novavax, Inc., this product is identified by NDC 80631-200 and is authorized under FDA application BLA125817.

Identification & Billing

NDC Package Code
80631-200-10
Package Description
10 SYRINGE, GLASS in 1 CARTON / .5 mL in 1 SYRINGE, GLASS (80631-200-01)
Product Code
80631-200
11-Digit Billing Format
80631020010

Clinical Specifications

Proprietary Name
Nuvaxovid Covid-19 Vaccine, Adjuvanted
Dosage Form
-
Usage Information
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.

Regulatory & Marketing

Labeler Name
Novavax, Inc.
FDA Application #
BLA125817
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-16-2025
End Marketing Date
08-26-2025
Listing Expiration
08-26-2025
Exclude Flag
D
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 80631-200-10 identifies a specific commercial package of 10 syringe, glass in 1 carton / .5 ml in 1 syringe, glass (80631-200-01) of Nuvaxovid Covid-19 Vaccine, Adjuvanted, labeled by Novavax, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Novavax, Inc. on May 16, 2025. The current certification is valid through August 26, 2025.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80631020010. 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)
80631-200-10
11-Digit CMS (5-4-2)
80631-0200-10

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