Mflusiva Injection, Suspension
NDC Package 80777-500-20

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

Package Information

Mflusiva (influenza vaccine, mrna) injection is mFLUSIVA is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B represented in the vaccine. This formulation utilizes a injection, suspension delivery system. Marketed by Moderna Us, Inc., this product is identified by NDC 80777-500 and is authorized under FDA application BLA125869.

Identification & Billing

NDC Package Code
80777-500-20
Package Description
10 SYRINGE, PLASTIC in 1 CARTON / .38 mL in 1 SYRINGE, PLASTIC (80777-500-18)
Product Code
80777-500
11-Digit Billing Format
80777050020

Clinical Specifications

Proprietary Name
Mflusiva
Non-Proprietary Name
Influenza Vaccine, Mrna
Substance Name
Rna-101-bfl3; Rna-101-bfl6; Rna-101-bfl5
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)
Usage Information
MFLUSIVA is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B represented in the vaccine. MFLUSIVA is approved for use in persons 50 years of age and older. The indication for persons 65 years of age and older is approved under accelerated approval based on immune responses [see Clinical Studies (14.3)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Regulatory & Marketing

Labeler Name
Moderna Us, Inc.
Product Type
Vaccine
FDA Application #
BLA125869
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
08-05-2026
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 80777-500-20 identifies a specific commercial package of 10 syringe, plastic in 1 carton / .38 ml in 1 syringe, plastic (80777-500-18) of Mflusiva, a vaccine label labeled by Moderna Us, Inc.. This injection, suspension is formulated for intramuscular use and contains rna-101-bfl3; rna-101-bfl6; rna-101-bfl5 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 05, 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: 80777050020. 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)
80777-500-20
11-Digit CMS (5-4-2)
80777-0500-20

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