Mnexspike Injection, Suspension
NDC Package 80777-401-60

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

Package Information

Mnexspike (covid-19 vaccine, mrna) injection is mNEXSPIKE 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).MNEXSPIKE is approved for use in individuals who are:•65 years of age and older, or•12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. This formulation utilizes a injection, suspension delivery system. Marketed by Moderna Us, Inc., this product is identified by NDC 80777-401 and is authorized under FDA application BLA125835.

Identification & Billing

NDC Package Code
80777-401-60
Package Description
10 SYRINGE, PLASTIC in 1 CARTON / .2 mL in 1 SYRINGE, PLASTIC (80777-401-17)
Product Code
80777-401
11-Digit Billing Format
80777040160

Clinical Specifications

Proprietary Name
Mnexspike
Non-Proprietary Name
Covid-19 Vaccine, Mrna
Substance Name
Cx-055610
Dosage Form
Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
CX-055610 10 ug/.2mL
Usage Information
MNEXSPIKE 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).MNEXSPIKE is approved for use in individuals who are:•65 years of age and older, or•12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

Regulatory & Marketing

Labeler Name
Moderna Us, Inc.
Product Type
Vaccine
FDA Application #
BLA125835
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
08-17-2026
Listing Expiration
12-31-2027
Exclude Flag
N
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 80777-401-60 identifies a specific commercial package of 10 syringe, plastic in 1 carton / .2 ml in 1 syringe, plastic (80777-401-17) of Mnexspike, a vaccine label labeled by Moderna Us, Inc.. This injection, suspension is formulated for intramuscular use and contains cx-055610 as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Moderna Us, Inc. on August 17, 2026. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80777040160. 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)
80777-401-60
11-Digit CMS (5-4-2)
80777-0401-60

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