Malarone Tablet, Film Coated
NDC Package 0173-0675-01

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

Malarone (atovaquone and proguanil hydrochloride) tablets is this medication contains 2 medicines: atovaquone and proguanil. This formulation utilizes a tablet, film coated delivery system. Marketed by Glaxosmithkline Llc, this product is identified by NDC 0173-0675 and is authorized under FDA application NDA021078.

Identification & Billing

NDC Package Code
0173-0675-01
Package Description
100 TABLET, FILM COATED in 1 BOTTLE
Product Code
0173-0675
11-Digit Billing Format
00173067501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 864675 - atovaquone 250 MG / proguanil HCl 100 MG Oral Tablet
  • RxCUI: 864675 - atovaquone 250 MG / proguanil hydrochloride 100 MG Oral Tablet
  • RxCUI: 864679 - MALARONE 250 MG / 100 MG Oral Tablet
  • RxCUI: 864679 - atovaquone 250 MG / proguanil hydrochloride 100 MG Oral Tablet [Malarone]
  • RxCUI: 864679 - Malarone 250/100 (atovaquone / proguanil HCl) Oral Tablet

Clinical Specifications

Proprietary Name
Malarone
Non-Proprietary Name
Atovaquone And Proguanil Hydrochloride
Substance Name
Atovaquone; Proguanil Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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
Glaxosmithkline Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021078
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-26-2000
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0173-0675). Click a package code to view its specific billing and regulatory data.

0173-0675-02
24 TABLET, FILM COATED in 1 DOSE PACK

* 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 0173-0675-01 identifies a specific commercial package of 100 tablet, film coated in 1 bottle of Malarone, a human prescription drug labeled by Glaxosmithkline Llc. This tablet, film coated is formulated for oral use and contains atovaquone; proguanil hydrochloride 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 Glaxosmithkline Llc on July 26, 2000. The current certification is valid through December 31, 2027.

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 Glaxosmithkline Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00173067501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
0173-0675-01
11-Digit CMS (5-4-2)
00173-0675-01

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