NDC 80777-283 Moderna Covid-19 Vaccine, Bivalent
Injection, Suspension Intramuscular

Product Information

What is NDC 80777-283?

The NDC code 80777-283 is assigned by the FDA to the product Moderna Covid-19 Vaccine, Bivalent 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 a single package with assigned NDC code 80777-283-99 10 vial, multi-dose in 1 carton / .4 ml in 1 vial, multi-dose (80777-283-02). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code80777-283
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Moderna Covid-19 Vaccine, Bivalent
Non-Proprietary Name 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.
Moderna Covid-19 Vaccine, Bivalent
Product Type 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.
Vaccine
Dosage FormInjection, 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) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Intramuscular - Administration within a muscle.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Moderna Us, Inc.
Labeler Code80777
Marketing Category 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.
EMERGENCY USE AUTHORIZATION -
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
09-23-2022
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Product Packages

NDC Code 80777-283-99

Package Description: 10 VIAL, MULTI-DOSE in 1 CARTON / .4 mL in 1 VIAL, MULTI-DOSE (80777-283-02)

Product Details

What are Moderna Covid-19 Vaccine, Bivalent 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.

Moderna Covid-19 Vaccine, Bivalent Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? 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: 2623378 - SARS-CoV-2 vaccine, mRNA-1273 bivalent original & OMICRON (BA.4/.5) Injectable Suspension, 6m through 5y (EUA)
  • RxCUI: 2623378 - SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 0.025 MG/ML / SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 OMICRON (BA.4/BA.5) 0.025 MG/ML Injectable Suspension

Moderna Covid-19 Vaccine, Bivalent 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.

* Please review the disclaimer below.

Moderna Covid-19 Vaccine, Bivalent Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Package/Label Display Panel



NDC 80777-283-02

Moderna COVID-19 Vaccine, Bivalent

Original and Omicron BA.4/BA.5

BOOSTER DOSES ONLY

Age 6m through 5y

For IM Use. For use under EUA.

Vial contains 2 doses of 0.2 mL

Scan carton QR code for expiry date

NDC 80777-283-99

Moderna COVID-19 Vaccine, Bivalent

Suspension for Intramuscular Injection

Original and Omicron BA.4/BA.5

For use under Emergency Use Authorization

BOOSTER DOSES ONLY

For age 6 months through 5 years

STORE FROZEN between -50° to -15°C (-58° to 5°F).

Protect from light

Ten multi-dose vials

Each vial contains 2 doses of 0.2 mL


* Please review the disclaimer below.