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    NDC 43063-0522-69 Atovaquone and Proguanil HCl 250; 100 mg/1; mg/1 Details

    Atovaquone and Proguanil HCl 250; 100 mg/1; mg/1

    Atovaquone and Proguanil HCl is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PD-Rx Pharmaceuticals, Inc.. The primary component is ATOVAQUONE; PROGUANIL HYDROCHLORIDE.

    Product Information

    NDC 43063-0522
    Product ID 43063-522_06471aaf-eb2a-9f20-e063-6294a90a75e5
    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 Generic
    Proprietary Name Atovaquone and Proguanil HCl
    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 PD-Rx Pharmaceuticals, Inc.
    Pharmaceutical Class Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category NDA AUTHORIZED GENERIC
    Application Number NDA021078
    Listing Certified Through 2024-12-31

    Package

    NDC 43063-0522-69 (43063052269)

    NDC Package Code 43063-522-69
    Billing NDC 43063052269
    Package 280 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-522-69)
    Marketing Start Date 2015-01-30
    NDC Exclude Flag N
    Pricing Information N/A