Coartem Tablet
NDC Package 0078-0568-45

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Coartem (artemether and lumefantrine) tablets is a medication used to treat malaria in adults and children. This formulation utilizes a tablet delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0568 and is authorized under FDA application NDA022268.

Identification & Billing

NDC Package Code
0078-0568-45
Package Description
24 TABLET in 1 BOTTLE
Product Code
0078-0568
11-Digit Billing Format
00078056845
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
24 EA
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

Clinical Specifications

Proprietary Name
Coartem
Non-Proprietary Name
Artemether And Lumefantrine
Substance Name
Artemether; Lumefantrine
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA022268
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-07-2009
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0078-0568-45 identifies a specific commercial package of 24 tablet in 1 bottle of Coartem, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. This tablet is formulated for oral use and contains artemether; lumefantrine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Novartis Pharmaceuticals Corporation on April 07, 2009. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

How is this Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078056845. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 24 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0078-0568-45
11-Digit CMS (5-4-2)
00078-0568-45

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.