Malarone
NDC Package 54569-5129-9

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

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

Malarone is this medication contains 2 medicines: atovaquone and proguanil. Marketed by A-s Medication Solutions, this product is identified by NDC 54569-5129 and is authorized under FDA application NDA021078.

Identification & Billing

NDC Package Code
54569-5129-9
Package Description
7 TABLET, FILM COATED in 1 BOTTLE
Product Code
11-Digit Billing Format
54569512909
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
7 EA

Clinical Specifications

Proprietary Name
Malarone
Dosage Form
-
Usage Information
This medication contains 2 medicines: atovaquone and proguanil. It is used to prevent and treat malaria caused by mosquito bites in countries where malaria is common. Malaria parasites can enter the body through these mosquito bites, and then 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 and other tissues. In some cases, you may need to take a different medication (such as primaquine) to complete your treatment. Both medications may be needed for a complete cure and to prevent the return of infection (relapse). Atovaquone/proguanil belongs to a class of drugs known as antimalarials. 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 traveling to areas where malaria occurs.

Regulatory & Marketing

Labeler Name
A-s Medication Solutions
FDA Application #
NDA021078
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-26-2000
Listing Expiration
12-31-2017
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 (54569-5129). Click a package code to view its specific billing and regulatory data.

16 TABLET, FILM COATED in 1 BOTTLE
24 TABLET, FILM COATED in 1 BOTTLE
14 TABLET, FILM COATED in 1 BOTTLE

* 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 54569-5129-9 identifies a specific commercial package of 7 tablet, film coated in 1 bottle of Malarone, labeled by A-s Medication Solutions. This product is billed for "EA" each discreet unit and contains an estimated amount of 7 billable units per package. 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 A-s Medication Solutions on July 26, 2000. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

This medication contains 2 medicines: atovaquone and proguanil. It is used to prevent and treat malaria caused by mosquito bites in countries where malaria is common. Malaria parasites can enter the body through these mosquito bites, and then 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 and other tissues. In some cases, you may need to take a different medication (such as primaquine) to complete your treatment. Both medications may be needed for a complete cure and to prevent the return of infection (relapse). Atovaquone/proguanil belongs to a class of drugs known as antimalarials. 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 traveling to areas where malaria occurs.

How is this A-s Medication Solutions product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54569512909. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 7 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 (5-4-1)
54569-5129-9
11-Digit CMS (5-4-2)
54569-5129-09

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