1. Home
  2. Labeler Index
  3. Moderna Us, Inc.
  4. NDC Product Code: 80777-345 Mresvia

NDC 80777-345 Mresvia

Respiratory Syncytial Virus Vaccine Suspension Intramuscular - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 80777-345?
  4. Mresvia Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

Get all the details for National Drug Code (NDC) 80777-345 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:
80777-345
Proprietary Name:
Mresvia
Non-Proprietary Name: [1]
Respiratory Syncytial Virus Vaccine
Substance Name: [2]
Rna-100-ar02
NDC Directory Status:
Vaccine
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route(s): [4]
Intramuscular - Administration within a muscle.
Labeler Name: [5]
Moderna Us, Inc.
Labeler Code:
80777
Product Label ID:
e5c837e7-41e8-496a-9c85-6b0453b35948
FDA Application Number: [6]
BLA125796
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
05-31-2024
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Navigator:

Code Structure Chart

Product Details

What is NDC 80777-345?

The NDC code 80777-345 is assigned by the FDA to the product Mresvia which is a vaccine label product labeled by Moderna Us, Inc.. The generic name of Mresvia is respiratory syncytial virus vaccine. The product's dosage form is suspension and is administered via intramuscular form. The product is distributed in 6 packages with assigned NDC codes 80777-345-61 10 syringe in 1 carton / .5 ml in 1 syringe (80777-345-01), 80777-345-62 1 syringe in 1 carton / .5 ml in 1 syringe (80777-345-01), 80777-345-63 2 syringe in 1 carton / .5 ml in 1 syringe (80777-345-01), 80777-345-89 2 syringe in 1 carton / .5 ml in 1 syringe (80777-345-01), 80777-345-90 1 syringe in 1 carton / .5 ml in 1 syringe (80777-345-01), 80777-345-96 10 syringe in 1 carton / .5 ml in 1 syringe (80777-345-01). 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 Mresvia?

MRESVIA is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older.

What are Mresvia Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Which are Mresvia UNII Codes?

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

Which are Mresvia 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 Mresvia?

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: 2685006 - respiratory syncytial virus pre-fusion F glycoprotein mRNA 50 MCG in 0.5 ML Prefilled Syringe
  • RxCUI: 2685006 - 0.5 ML respiratory syncytial virus pre-fusion F glycoprotein mRNA 0.1 MG/ML Prefilled Syringe
  • RxCUI: 2685006 - respiratory syncytial virus pre-fusion F glycoprotein mRNA 50 MCG per 0.5 ML Prefilled Syringe
  • RxCUI: 2685012 - mRESVIA 50 MCG in 0.5 ML Prefilled Syringe
  • RxCUI: 2685012 - 0.5 ML respiratory syncytial virus pre-fusion F glycoprotein mRNA 0.1 MG/ML Prefilled Syringe [Mresvia]

* Please review the disclaimer below.

Patient Education

RSV (Respiratory Syncytial Virus) Vaccine, mRNA


Why get vaccinated? RSV vaccine, mRNA can prevent disease caused by infection with Respiratory Syncytial Virus (RSV). RSV disease refers to an infection of the lower respiratory tract caused by RSV. RSV is a common virus that causes mild, cold-like symptoms. However, RSV disease can be more serious in infants and older adults. Those older adults at higher risk of severe disease from RSV disease include those: with chronic heart or lung diseases with weakened immune systems nursing home or long-term care facility residents RSV is usually spread through direct contact with the virus such as droplets from another person's cough or sneeze contacting your eyes, nose or mouth. It can also be spread by touching a surface that has a virus on it, such as a doorknob, and then touching your face before washing your hands. Mild symptoms of RSV disease typically resolve in a week or two and may include the following: runny nose decrease in appetite coughing sneezing fever wheezing In individuals at high risk of serious disease as previously described, RSV may cause shortness of breath and low oxygen levels or may also worsen chronic heart or lung disease, leading to a hospital stay and even potentially death.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

[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.

[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".