Atovaquone And Proguanil Hydrochloride
NDC Package 10544-909-10

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.

Atovaquone And Proguanil Hydrochloride is tablets are indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. Marketed by Blenheim Pharmacal, Inc., this product is identified by NDC 10544-909 and is authorized under FDA application ANDA091211.

Identification & Billing

NDC Package Code
10544-909-10
Package Description
10 TABLET, FILM COATED in 1 BOTTLE
Product Code
10544-909
11-Digit Billing Format
10544090910
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 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

Clinical Specifications

Proprietary Name
Atovaquone And Proguanil Hydrochloride
Dosage Form
-
Usage Information
Atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported.

Regulatory & Marketing

Labeler Name
Blenheim Pharmacal, Inc.
FDA Application #
ANDA091211
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-19-2015
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 (10544-909). Click a package code to view its specific billing and regulatory data.

10544-909-05
5 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 10544-909-10 identifies a specific commercial package of 10 tablet, film coated in 1 bottle of Atovaquone And Proguanil Hydrochloride, labeled by Blenheim Pharmacal, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 10 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 Blenheim Pharmacal, Inc. on March 19, 2015. The current certification is valid through December 31, 2017.

How is this Blenheim Pharmacal, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10544090910. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 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 (5-3-2)
10544-909-10
11-Digit CMS (5-4-2)
10544-0909-10

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