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    NDC 00173-0675-01 MALARONE 250; 100 mg/1; mg/1 Details

    MALARONE 250; 100 mg/1; mg/1

    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 Information

    NDC 00173-0675
    Product ID 0173-0675_a4544599-2e43-4fb8-b38d-84613dac6729
    Associated GPIs 13990002050320
    GCN Sequence Number 045855
    GCN Sequence Number Description atovaquone/proguanil HCl TABLET 250-100 MG ORAL
    HIC3 W4A
    HIC3 Description ANTIMALARIAL DRUGS
    GCN 89891
    HICL Sequence Number 016487
    HICL Sequence Number Description ATOVAQUONE/PROGUANIL HCL
    Brand/Generic Brand
    Proprietary Name MALARONE
    Proprietary Name Suffix n/a
    Non-Proprietary Name atovaquone and proguanil hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 250; 100
    Active Ingredient Units mg/1; mg/1
    Substance Name ATOVAQUONE; PROGUANIL HYDROCHLORIDE
    Labeler Name GlaxoSmithKline LLC
    Pharmaceutical Class Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA021078
    Listing Certified Through 2024-12-31

    Package

    NDC 00173-0675-01 (00173067501)

    NDC Package Code 0173-0675-01
    Billing NDC 00173067501
    Package 100 TABLET, FILM COATED in 1 BOTTLE (0173-0675-01)
    Marketing Start Date 2000-07-26
    NDC Exclude Flag N
    Pricing Information N/A