Atovaquone Suspension
NDC Package 0904-7459-53

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

Atovaquone (atovaquone oral suspension) suspension is atovaquone is used to prevent or treat a serious lung infection called Pneumocystis pneumonia (PCP). This formulation utilizes a suspension delivery system. Marketed by Major Pharmaceuticals, this product is identified by NDC 0904-7459 and is authorized under FDA application ANDA214272.

Identification & Billing

NDC Package Code
0904-7459-53
Package Description
7 TRAY in 1 CASE / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7459-41)
Product Code
0904-7459
11-Digit Billing Format
00904745953
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Atovaquone
Non-Proprietary Name
Atovaquone Oral Suspension
Substance Name
Atovaquone
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ATOVAQUONE 750 mg/5mL
Pharmacologic Class
Usage Information
Atovaquone is used to prevent or treat a serious lung infection called Pneumocystis pneumonia (PCP). This medication helps to stop infection symptoms such as fever, cough, tiredness, and shortness of breath.

Regulatory & Marketing

Labeler Name
Major Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
ANDA214272
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-08-2024
Listing Expiration
12-31-2026
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 (0904-7459). Click a package code to view its specific billing and regulatory data.

0904-7459-25
3 TRAY in 1 CASE / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7459-41)

* 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 0904-7459-53 identifies a specific commercial package of 7 tray in 1 case / 6 cup, unit-dose in 1 tray / 5 ml in 1 cup, unit-dose (0904-7459-41) of Atovaquone, a human prescription drug labeled by Major Pharmaceuticals. This suspension is formulated for oral use and contains atovaquone 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 Major Pharmaceuticals on July 08, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Atovaquone is used to prevent or treat a serious lung infection called Pneumocystis pneumonia (PCP). This medication helps to stop infection symptoms such as fever, cough, tiredness, and shortness of breath.

How is this Major Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00904745953. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
0904-7459-53
11-Digit CMS (5-4-2)
00904-7459-53

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