NDC 0173-0676

MALARONE

Atovaquone And Proguanil Hydrochloride

MALARONE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Atovaquone; Proguanil Hydrochloride.

Product ID0173-0676_08009f86-6d3c-496f-9995-b5bb76f8d9a4
NDC0173-0676
Product TypeHuman Prescription Drug
Proprietary NameMALARONE
Generic NameAtovaquone And Proguanil Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2000-07-26
Marketing CategoryNDA / NDA
Application NumberNDA021078
Labeler NameGlaxoSmithKline LLC
Substance NameATOVAQUONE; PROGUANIL HYDROCHLORIDE
Active Ingredient Strength63 mg/1; mg/1
Pharm ClassesAntimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0173-0676-01

100 TABLET, FILM COATED in 1 BOTTLE (0173-0676-01)
Marketing Start Date2000-07-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0173-0676-01 [00173067601]

MALARONE TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-07-26

Drug Details

Active Ingredients

IngredientStrength
ATOVAQUONE62.5 mg/1

OpenFDA Data

SPL SET ID:fc22e8d8-3bfb-4f70-a599-dd81262a4887
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 864675
  • 864681
  • 864679
  • 864685
    • UPC Code
  • 0301730676016
  • 0301730675019

    • Pharmacological Class

    • Antimalarial [EPC]
    • Antiprotozoal [EPC]
    • Antimalarial [EPC]
    • Dihydrofolate Reductase Inhibitors [MoA]
    • Antimalarial [EPC]
    • Antiprotozoal [EPC]
    • Antimalarial [EPC]
    • Dihydrofolate Reductase Inhibitors [MoA]

    NDC Crossover Matching brand name "MALARONE" or generic name "Atovaquone And Proguanil Hydrochloride"

    NDCBrand NameGeneric Name
    0173-0675MALARONEatovaquone and proguanil hydrochloride
    0173-0676MALARONEatovaquone and proguanil hydrochloride
    50090-0687MALARONEatovaquone and proguanil hydrochloride
    50090-0688MALARONEatovaquone and proguanil hydrochloride
    55289-747MALARONEMALARONE
    43063-522Atovaquone and Proguanil HClatovaquone and proguanil hydrochloride
    50090-2980Atovaquone and Proguanil HClatovaquone and proguanil hydrochloride
    0378-4160Atovaquone and Proguanil Hydrochlorideatovaquone and proguanil hydrochloride
    0378-4162Atovaquone and Proguanil Hydrochlorideatovaquone and proguanil hydrochloride
    10544-909Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil Hydrochloride
    33261-900Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil Hydrochloride
    42254-150Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil Hydrochloride
    43063-393Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil Hydrochloride
    50090-1302Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil Hydrochloride

    Trademark Results [MALARONE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MALARONE
    MALARONE
    75751708 2622687 Live/Registered
    GLAXO GROUP LIMITED
    1999-07-15
    MALARONE
    MALARONE
    75022789 not registered Dead/Abandoned
    Wellcome Foundation Limited, The
    1995-11-21
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.