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    NDC 57841-1200-01 Aemcolo 194 mg/1 Details

    Aemcolo 194 mg/1

    Aemcolo is a ORAL TABLET, DELAYED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by RedHill Biopharma Ltd. The primary component is RIFAMYCIN.

    Product Information

    NDC 57841-1200
    Product ID 57841-1200_9377a845-abf1-4c32-84e6-51ee3473c9d2
    Associated GPIs 16000048200620
    GCN Sequence Number 079335
    GCN Sequence Number Description rifamycin sodium TABLET DR 194 MG ORAL
    HIC3 W9C
    HIC3 Description RIFAMYCINS AND RELATED DERIVATIVE ANTIBIOTICS
    GCN 45823
    HICL Sequence Number 011697
    HICL Sequence Number Description RIFAMYCIN SODIUM
    Brand/Generic Brand
    Proprietary Name Aemcolo
    Proprietary Name Suffix n/a
    Non-Proprietary Name Rifamycin
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, DELAYED RELEASE
    Route ORAL
    Active Ingredient Strength 194
    Active Ingredient Units mg/1
    Substance Name RIFAMYCIN
    Labeler Name RedHill Biopharma Ltd
    Pharmaceutical Class Rifamycin Antibacterial [EPC], Rifamycins [CS]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA210910
    Listing Certified Through 2024-12-31

    Package

    NDC 57841-1200-01 (57841120001)

    NDC Package Code 57841-1200-1
    Billing NDC 57841120001
    Package 2 BLISTER PACK in 1 CARTON (57841-1200-1) / 6 TABLET, DELAYED RELEASE in 1 BLISTER PACK (57841-1200-0)
    Marketing Start Date 2021-07-01
    NDC Exclude Flag N
    Pricing Information N/A