Mresvia Suspension
NDC 80777-345

View dosage, usage, ingredients, routes, and UNII mappings.
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

Mresvia (respiratory syncytial virus vaccine) is a BLA-approved product labeled by Moderna Us, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a suspension for intramuscular administration. This product entry covers the primary NDC 80777-345 and 6 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

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
Code Navigator:

Clinical Specifications

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 & Regulatory Data

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.

Marketing Timeline

Start Marketing Date: [9]
05-31-2024
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 80777-345?

The NDC code 80777-345 is assigned by the FDA to the product Mresvia. It is commonly known by its generic name, respiratory syncytial virus vaccine. This pharmaceutical product is labeled by Moderna Us, Inc. and is currently categorized as listed product. The medication is a suspension administered via intramuscular route. In terms of distribution, this product is available in 6 different package configurations. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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 Active Ingredients of this product?

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 the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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 full disclaimer at the bottom of this page.

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 full disclaimer at the bottom of this page.

Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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".