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  5. NDC Package Code: 50090-2980-0 Atovaquone And Proguanil Hcl

NDC Package 50090-2980-0 Atovaquone And Proguanil Hcl

Atovaquone And Proguanil Hydrochloride Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
50090-2980-0
Package Description:
7 TABLET, FILM COATED in 1 BOTTLE
Product Code:
50090-2980
Proprietary Name:
Atovaquone And Proguanil Hcl
Non-Proprietary Name:
Atovaquone And Proguanil Hydrochloride
Substance Name:
Atovaquone; Proguanil Hydrochloride
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)].
11-Digit NDC Billing Format:
50090298000
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
7 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 864675 - atovaquone 250 MG / proguanil HCl 100 MG Oral Tablet
  • RxCUI: 864675 - atovaquone 250 MG / proguanil hydrochloride 100 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    A-s Medication Solutions
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ATOVAQUONE 250 mg/1
  • PROGUANIL HYDROCHLORIDE 100 mg/1
    • Pharmacologic Class(es):
  • Antimalarial - [EPC] (Established Pharmacologic Class)
  • Antimalarial - [EPC] (Established Pharmacologic Class)
  • Antiprotozoal - [EPC] (Established Pharmacologic Class)
  • Dihydrofolate Reductase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    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 Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    50090-2980-112 TABLET, FILM COATED in 1 BOTTLE
    50090-2980-214 TABLET, FILM COATED in 1 BOTTLE
    50090-2980-316 TABLET, FILM COATED in 1 BOTTLE
    50090-2980-424 TABLET, FILM COATED in 1 BOTTLE
    50090-2980-55 TABLET, FILM COATED in 1 BOTTLE
    50090-2980-610 TABLET, FILM COATED in 1 BOTTLE
    50090-2980-7100 TABLET, FILM COATED in 1 BOTTLE
    50090-2980-820 TABLET, FILM COATED in 1 BOTTLE
    50090-2980-930 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 50090-2980-0?

    The NDC Packaged Code 50090-2980-0 is assigned to a package of 7 tablet, film coated in 1 bottle of Atovaquone And Proguanil Hcl, a human prescription drug labeled by A-s Medication Solutions. The product's dosage form is tablet, film coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 7 billable units per package.

    Is NDC 50090-2980 included in the NDC Directory?

    Yes, Atovaquone And Proguanil Hcl with product code 50090-2980 is active and included in the NDC Directory. The product was first marketed by A-s Medication Solutions on July 27, 2012 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 50090-2980-0?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 7.

    What is the 11-digit format for NDC 50090-2980-0?

    The 11-digit format is 50090298000. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-150090-2980-05-4-250090-2980-00