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    NDC 65649-0303-01 XIFAXAN 550 mg/1 Details

    XIFAXAN 550 mg/1

    XIFAXAN is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Salix Pharmaceuticals, Inc.. The primary component is RIFAXIMIN.

    Product Information

    NDC 65649-0303
    Product ID 65649-303_0a33f9a9-1faa-7cdf-e063-6294a90adca1
    Associated GPIs 16000049000340
    GCN Sequence Number 066295
    GCN Sequence Number Description rifaximin TABLET 550 MG ORAL
    HIC3 W9C
    HIC3 Description RIFAMYCINS AND RELATED DERIVATIVE ANTIBIOTICS
    GCN 28530
    HICL Sequence Number 020401
    HICL Sequence Number Description RIFAXIMIN
    Brand/Generic Brand
    Proprietary Name XIFAXAN
    Proprietary Name Suffix n/a
    Non-Proprietary Name rifaximin
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 550
    Active Ingredient Units mg/1
    Substance Name RIFAXIMIN
    Labeler Name Salix Pharmaceuticals, Inc.
    Pharmaceutical Class Rifamycin Antibacterial [EPC], Rifamycins [CS]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA021361
    Listing Certified Through 2024-12-31

    Package

    NDC 65649-0303-01 (65649030301)

    NDC Package Code 65649-303-01
    Billing NDC 65649030301
    Package 3 CARTON in 1 TRAY (65649-303-01) / 1 BLISTER PACK in 1 CARTON / 2 TABLET in 1 BLISTER PACK
    Marketing Start Date 2010-05-01
    NDC Exclude Flag N
    Pricing Information N/A