Atovaquone Oral Suspension
NDC Package 10702-223-21

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

Package Information

Atovaquone Oral Suspension (atovaquone) 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 Kvk-tech, Inc., this product is identified by NDC 10702-223 and is authorized under FDA application ANDA210510.

Identification & Billing

NDC Package Code
10702-223-21
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 210 mL in 1 BOTTLE, PLASTIC
Product Code
10702-223
11-Digit Billing Format
10702022321
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 Oral Suspension
Non-Proprietary Name
Atovaquone
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
Kvk-tech, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA210510
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-29-2019
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 10702-223-21 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 210 ml in 1 bottle, plastic of Atovaquone Oral Suspension, a human prescription drug labeled by Kvk-tech, Inc.. 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 Kvk-tech, Inc. on March 29, 2019. The current certification is valid through December 31, 2027.

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 Kvk-tech, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10702022321. 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)
10702-223-21
11-Digit CMS (5-4-2)
10702-0223-21

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