1. Home
  2. Labeler Index
  3. Moderna Us, Inc.
  4. NDC Product Code: 80777-291 Moderna Covid-19 Vaccine

NDC 80777-291 Moderna Covid-19 Vaccine

Injection, Suspension Intramuscular - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 80777-291?
  4. Active Ingredients
  5. NDC to RxNorm Crosswalk

Product Information

Get all the details for National Drug Code (NDC) 80777-291 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:
80777-291
Proprietary Name:
Moderna Covid-19 Vaccine
Non-Proprietary Name: [1]
Moderna Covid-19 Vaccine
Substance Name: [2]
Cx-046684
NDC Directory Status:
Vaccine
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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(s): [4]
Intramuscular - Administration within a muscle.
Labeler Name: [5]
Moderna Us, Inc.
Labeler Code:
80777
Product Label ID:
530786f0-58d9-4370-88f0-6e98e4b85183
Marketing Category: [8]
EMERGENCY USE AUTHORIZATION -
Start Marketing Date: [9]
08-20-2024
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Navigator:

Code Structure Chart

Product Details

What is NDC 80777-291?

The NDC code 80777-291 is assigned by the FDA to the product Moderna Covid-19 Vaccine which is a vaccine label product labeled by Moderna Us, Inc.. The product's dosage form is injection, suspension and is administered via intramuscular form. The product is distributed in 2 packages with assigned NDC codes 80777-291-80 10 syringe, plastic in 1 carton / .25 ml in 1 syringe, plastic (80777-291-09), 80777-291-81 10 syringe, plastic in 1 carton / .25 ml in 1 syringe, plastic (80777-291-09). 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 Moderna Covid-19 Vaccine 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.

What is the NDC to RxNorm Crosswalk for Moderna Covid-19 Vaccine?

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: 2664729 - SARS-CoV-2 (COVID-19) vaccine 2023-2024, mRNA-1273 OMICRON (XBB.1.5) 0.25 ML Injection, 6m through 11y (EUA)
  • RxCUI: 2664729 - 0.25 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 OMICRON (XBB.1.5) 0.1 MG/ML Injection
  • RxCUI: 2691172 - SARS-CoV-2 (COVID-19) vaccine 2024-2025, mRNA-1273 OMICRON (KP.2) 0.25 ML Prefilled Syringe, 6m through 11y
  • RxCUI: 2691172 - 0.25 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 OMICRON (KP.2) 0.1 MG/ML Prefilled Syringe

* 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.

[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".