NDC 0078-0568 Coartem

Artemether And Lumefantrine Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0078-0568
Proprietary Name:
Coartem
Non-Proprietary Name: [1]
Artemether And Lumefantrine
Substance Name: [2]
Artemether; Lumefantrine
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Novartis Pharmaceuticals Corporation
    Labeler Code:
    0078
    FDA Application Number: [6]
    NDA022268
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    04-07-2009
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    YELLOW (C48330)
    Shape:
    ROUND (C48348)
    Size(s):
    9 MM
    Imprint(s):
    N;C;CG
    Score:
    2

    Product Packages

    NDC Code 0078-0568-45

    Package Description: 24 TABLET in 1 BOTTLE

    Price per Unit: $4.95952 per EA

    Product Details

    What is NDC 0078-0568?

    The NDC code 0078-0568 is assigned by the FDA to the product Coartem which is a human prescription drug product labeled by Novartis Pharmaceuticals Corporation. The generic name of Coartem is artemether and lumefantrine. The product's dosage form is tablet and is administered via oral form. The product is distributed in a single package with assigned NDC code 0078-0568-45 24 tablet in 1 bottle . 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 Coartem?

    This medication is used to treat malaria in adults and children. The two ingredients in this medication belong to a class of drugs known as antimalarials. Malaria is an infection caused by mosquito bites received while traveling or living in regions of the world where malaria is common. Malaria parasites enter the body, and live in body tissues such as red blood cells or the liver. This medication is used to kill the malaria parasites living inside red blood cells. In some cases, you may need to take a different medication (such as primaquine) to kill the malaria parasites living in the liver. Both treatments may be needed for a complete cure and to avoid the return of infection (relapse). This product is not used to prevent malaria. The United States Centers for Disease Control provide updated guidelines and travel recommendations for the prevention and treatment of malaria in different parts of the world. Discuss the most recent information with your doctor before starting treatment with this medication.

    What are Coartem 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.
    • ARTEMETHER 20 mg/1 - An artemisinin derivative that is used in the treatment of MALARIA.
    • LUMEFANTRINE 120 mg/1 - A fluorene derivative that is used in combination with ARTEMETHER for the treatment of MALARIA (see ARTEMETHER-LUMEFANTRINE DRUG COMBINATION).

    Which are Coartem UNII Codes?

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

    Which are Coartem 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 Coartem?

    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: 847731 - artemether 20 MG / lumefantrine 120 MG Oral Tablet
    • RxCUI: 847734 - Coartem 20 MG / 120 MG Oral Tablet
    • RxCUI: 847734 - artemether 20 MG / lumefantrine 120 MG Oral Tablet [Coartem]
    • RxCUI: 847734 - Coartem (artemether 20 MG / lumefantrine 120 MG) Oral Tablet

    Which are the Pharmacologic Classes for Coartem?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Artemether and Lumefantrine


    The combination of artemether and lumefantrine is used to treat certain kinds of malaria infections (a serious infection that is spread by mosquitoes in certain parts of the world and can cause death). Artemether and lumefantrine should not be used to prevent malaria. Artemether and lumefantrine is in a class of medications called antimalarials. It works by killing the organisms that cause malaria.
    [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 ("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".