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  5. NDC Package Code: 0078-0568-45 Coartem

NDC Package 0078-0568-45 Coartem

Artemether And Lumefantrine Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0078-0568-45
Package Description:
24 TABLET in 1 BOTTLE
Product Code:
0078-0568
Proprietary Name:
Coartem
Non-Proprietary Name:
Artemether And Lumefantrine
Substance Name:
Artemether; Lumefantrine
Usage Information:
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.
11-Digit NDC Billing Format:
00078056845
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
24 EA
NDC to RxNorm Crosswalk:
  • 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Novartis Pharmaceuticals Corporation
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ARTEMETHER 20 mg/1
  • LUMEFANTRINE 120 mg/1
    • Pharmacologic Class(es):
  • Antimalarial - [EPC] (Established Pharmacologic Class)
  • Antimalarial - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA022268
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    04-07-2009
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0078-0568-45?

    The NDC Packaged Code 0078-0568-45 is assigned to a package of 24 tablet in 1 bottle of Coartem, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is tablet and is administered via oral form.

    Is NDC 0078-0568 included in the NDC Directory?

    Yes, Coartem with product code 0078-0568 is active and included in the NDC Directory. The product was first marketed by Novartis Pharmaceuticals Corporation on April 07, 2009 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0078-0568-45?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 24.

    What is the 11-digit format for NDC 0078-0568-45?

    The 11-digit format is 00078056845. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20078-0568-455-4-200078-0568-45