Atovaquone
NDC Package 50268-086-12

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Atovaquone is used to prevent or treat a serious lung infection called Pneumocystis pneumonia (PCP). Marketed by Avpak, this product is identified by NDC 50268-086 and is authorized under FDA application ANDA210692.

Identification & Billing

NDC Package Code
50268-086-12
Package Description
20 CUP, UNIT-DOSE in 1 BOX / 5 mL in 1 CUP, UNIT-DOSE (50268-086-11)
Product Code
50268-086
11-Digit Billing Format
50268008612
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Atovaquone
Dosage Form
-
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
Avpak
FDA Application #
ANDA210692
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-07-2020
End Marketing Date
09-30-2025
Listing Expiration
09-30-2025
Exclude Flag
D
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50268-086-12 identifies a specific commercial package of 20 cup, unit-dose in 1 box / 5 ml in 1 cup, unit-dose (50268-086-11) of Atovaquone, labeled by Avpak. 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 Avpak on May 07, 2020. The current certification is valid through September 30, 2025.

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 Avpak product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50268008612. 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 (5-3-2)
50268-086-12
11-Digit CMS (5-4-2)
50268-0086-12

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