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    NDC 50268-0086-12 Atovaquone 750 mg/5mL Details

    Atovaquone 750 mg/5mL

    Atovaquone is a ORAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AvPAK. The primary component is ATOVAQUONE.

    Product Information

    NDC 50268-0086
    Product ID 50268-086_d5cbb80c-c326-ac08-e053-2995a90a264d
    Associated GPIs 16400020001820
    GCN Sequence Number 023399
    GCN Sequence Number Description atovaquone ORAL SUSP 750 MG/5ML ORAL
    HIC3 W4K
    HIC3 Description ANTIPROTOZOAL DRUGS,MISCELLANEOUS
    GCN 34490
    HICL Sequence Number 006619
    HICL Sequence Number Description ATOVAQUONE
    Brand/Generic Generic
    Proprietary Name Atovaquone
    Proprietary Name Suffix n/a
    Non-Proprietary Name Atovaquone
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SUSPENSION
    Route ORAL
    Active Ingredient Strength 750
    Active Ingredient Units mg/5mL
    Substance Name ATOVAQUONE
    Labeler Name AvPAK
    Pharmaceutical Class Antimalarial [EPC], Antiprotozoal [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA210692
    Listing Certified Through 2025-12-31

    Package

    NDC 50268-0086-12 (50268008612)

    NDC Package Code 50268-086-12
    Billing NDC 50268008612
    Package 20 CUP, UNIT-DOSE in 1 BOX (50268-086-12) / 5 mL in 1 CUP, UNIT-DOSE (50268-086-11)
    Marketing Start Date 2020-05-07
    NDC Exclude Flag N
    Pricing Information N/A