Atovaquone And Proguanil Hcl Tablet, Film Coated
NDC Package 50090-2980-2

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 And Proguanil Hcl (atovaquone and proguanil hydrochloride) tablets is •Atovaquone and Proguanil Hydrochloride tablets are contraindicated in individuals with known hypersensitivity reactions (e.g., anaphylaxis, erythema multiforme or Stevens-Johnson syndrome, angioedema, vasculitis) to atovaquone or proguanil hydrochloride or any component of the formulation.•Atovaquone and Proguanil Hydrochloride tablets are contraindicated for prophylaxis of P. falciparum malaria in patients with severe renal impairment (creatinine clearance <30 mL/min) because of pancytopenia in patients with severe renal impairment treated with proguanil [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)]. This formulation utilizes a tablet, film coated delivery system. Marketed by A-s Medication Solutions, this product is identified by NDC 50090-2980 and is authorized under FDA application NDA021078.

Identification & Billing

NDC Package Code
50090-2980-2
Package Description
14 TABLET, FILM COATED in 1 BOTTLE
Product Code
50090-2980
11-Digit Billing Format
50090298002
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
14 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 Hcl
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
•Atovaquone and Proguanil Hydrochloride tablets are contraindicated in individuals with known hypersensitivity reactions (e.g., anaphylaxis, erythema multiforme or Stevens-Johnson syndrome, angioedema, vasculitis) to atovaquone or proguanil hydrochloride or any component of the formulation.•Atovaquone and Proguanil Hydrochloride tablets are contraindicated for prophylaxis of P. falciparum malaria in patients with severe renal impairment (creatinine clearance <30 mL/min) because of pancytopenia in patients with severe renal impairment treated with proguanil [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Regulatory & Marketing

Labeler Name
A-s Medication Solutions
Product Type
Human Prescription Drug
FDA Application #
NDA021078
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
07-27-2012
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 (50090-2980). Click a package code to view its specific billing and regulatory data.

50090-2980-0
7 TABLET, FILM COATED in 1 BOTTLE
50090-2980-1
12 TABLET, FILM COATED in 1 BOTTLE
50090-2980-3
16 TABLET, FILM COATED in 1 BOTTLE
50090-2980-4
24 TABLET, FILM COATED in 1 BOTTLE
50090-2980-5
5 TABLET, FILM COATED in 1 BOTTLE
50090-2980-6
10 TABLET, FILM COATED in 1 BOTTLE
50090-2980-7
100 TABLET, FILM COATED in 1 BOTTLE
50090-2980-8
20 TABLET, FILM COATED in 1 BOTTLE
50090-2980-9
30 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 50090-2980-2 identifies a specific commercial package of 14 tablet, film coated in 1 bottle of Atovaquone And Proguanil Hcl, a human prescription drug labeled by A-s Medication Solutions. This product is billed for "EA" each discreet unit and contains an estimated amount of 14 billable units per package. 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 A-s Medication Solutions on July 27, 2012. The current certification is valid through December 31, 2026.

How is this A-s Medication Solutions product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50090298002. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 14 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 (5-4-1)
50090-2980-2
11-Digit CMS (5-4-2)
50090-2980-02

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