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    NDC 00078-0568-45 COARTEM 20; 120 mg/1; mg/1 Details

    COARTEM 20; 120 mg/1; mg/1

    COARTEM is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is ARTEMETHER; LUMEFANTRINE.

    Product Information

    NDC 00078-0568
    Product ID 0078-0568_d600e1b1-d1e7-44e9-98d7-4817fe2bf9e8
    Associated GPIs 13990002030320
    GCN Sequence Number 050710
    GCN Sequence Number Description artemether/lumefantrine TABLET 20MG-120MG ORAL
    HIC3 W4A
    HIC3 Description ANTIMALARIAL DRUGS
    GCN 17848
    HICL Sequence Number 024021
    HICL Sequence Number Description ARTEMETHER/LUMEFANTRINE
    Brand/Generic Brand
    Proprietary Name COARTEM
    Proprietary Name Suffix n/a
    Non-Proprietary Name artemether and lumefantrine
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 20; 120
    Active Ingredient Units mg/1; mg/1
    Substance Name ARTEMETHER; LUMEFANTRINE
    Labeler Name Novartis Pharmaceuticals Corporation
    Pharmaceutical Class Antimalarial [EPC], Antimalarial [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA022268
    Listing Certified Through 2024-12-31

    Package

    NDC 00078-0568-45 (00078056845)

    NDC Package Code 0078-0568-45
    Billing NDC 00078056845
    Package 24 TABLET in 1 BOTTLE (0078-0568-45)
    Marketing Start Date 2009-04-07
    NDC Exclude Flag N
    Pricing Information N/A