Coartem
NDC Package 76413-154-06

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Coartem is a medication used to treat malaria in adults and children. Marketed by Central Texas Community Health Centers, this product is identified by NDC 76413-154 and is authorized under FDA application NDA022268.

Identification & Billing

NDC Package Code
76413-154-06
Package Description
6 TABLET in 1 BOTTLE, PLASTIC
Product Code
76413-154
11-Digit Billing Format
76413015406
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
Dosage Form
-
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
Central Texas Community Health Centers
FDA Application #
NDA022268
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-07-2009
Listing Expiration
12-31-2019
Exclude Flag
I
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (76413-154). Click a package code to view its specific billing and regulatory data.

76413-154-12
12 TABLET in 1 BOTTLE, PLASTIC
76413-154-18
18 TABLET in 1 BOTTLE, PLASTIC
76413-154-24
24 TABLET in 1 BOTTLE, PLASTIC

* 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 76413-154-06 identifies a specific commercial package of 6 tablet in 1 bottle, plastic of Coartem, labeled by Central Texas Community Health Centers. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Central Texas Community Health Centers on April 07, 2009. The current certification is valid through December 31, 2019.

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 Central Texas Community Health Centers product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76413015406. 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 (5-3-2)
76413-154-06
11-Digit CMS (5-4-2)
76413-0154-06

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