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  4. NDC Product Code: 0006-5055 Lagevrio

NDC 0006-5055 Lagevrio

Molnupiravir Capsule Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0006-5055?
  5. Lagevrio Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Patient Education

Product Information

NDC Product Code:
0006-5055
Proprietary Name:
Lagevrio
Non-Proprietary Name: [1]
Molnupiravir
Substance Name: [2]
Molnupiravir
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Merck Sharp & Dohme Llc
    Labeler Code:
    0006
    Product Label ID:
    1b0da643-ab23-4a0b-a9ec-a434522446d0
    Marketing Category: [8]
    EMERGENCY USE AUTHORIZATION -
    Start Marketing Date: [9]
    12-23-2021
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    ORANGE (C48331 - SWEDISH ORANGE OPAQUE)
    Shape:
    CAPSULE (C48336)
    Size(s):
    22 MM
    Imprint(s):
    LOGO;82
    Score:
    1

    Product Packages

    NDC Code 0006-5055-06

    Package Description: 40 CAPSULE in 1 BOTTLE, PLASTIC

    NDC Code 0006-5055-07

    Package Description: 40 CAPSULE in 1 BOTTLE, PLASTIC

    NDC Code 0006-5055-09

    Package Description: 40 CAPSULE in 1 BOTTLE, PLASTIC

    Product Details

    What is NDC 0006-5055?

    The NDC code 0006-5055 is assigned by the FDA to the product Lagevrio which is a human prescription drug product labeled by Merck Sharp & Dohme Llc. The generic name of Lagevrio is molnupiravir. The product's dosage form is capsule and is administered via oral form. The product is distributed in 3 packages with assigned NDC codes 0006-5055-06 40 capsule in 1 bottle, plastic , 0006-5055-07 40 capsule in 1 bottle, plastic , 0006-5055-09 40 capsule in 1 bottle, plastic . 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 Lagevrio?

    No contraindications have been identified based on the limited available data on the emergency use of molnupiravir authorized under this EUA.

    What are Lagevrio 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 Lagevrio UNII Codes?

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

    Which are Lagevrio 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 Lagevrio?

    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:

    * Please review the disclaimer below.

    Patient Education

    Molnupiravir


    Molnupiravir is used to treat coronavirus disease 2019 (COVID-19 infection) caused by the SARS-CoV-2 virus in adults who have mild to moderate symptoms and are at risk of severe disease that could result in hospitalization or death when other treatments are either not available or cannot be used. Molnupiravir is in a class of medications called antivirals. It works by stopping the virus from spreading in the body..
    [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.

    [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 ("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".