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    NDC 10135-0738-01 Rifabutin 150 mg/1 Details

    Rifabutin 150 mg/1

    Rifabutin is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Marlex Pharmaceuticals, Inc.. The primary component is RIFABUTIN.

    Product Information

    NDC 10135-0738
    Product ID 10135-738_f5f14f8b-5066-8471-e053-2995a90afce9
    Associated GPIs 09000075000120
    GCN Sequence Number 018766
    GCN Sequence Number Description rifabutin CAPSULE 150 MG ORAL
    HIC3 W2E
    HIC3 Description ANTI-MYCOBACTERIUM AGENTS
    GCN 29810
    HICL Sequence Number 007626
    HICL Sequence Number Description RIFABUTIN
    Brand/Generic Generic
    Proprietary Name Rifabutin
    Proprietary Name Suffix n/a
    Non-Proprietary Name Rifabutin
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 150
    Active Ingredient Units mg/1
    Substance Name RIFABUTIN
    Labeler Name Marlex Pharmaceuticals, Inc.
    Pharmaceutical Class Rifamycin Antimycobacterial [EPC], Rifamycins [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA215041
    Listing Certified Through 2024-12-31

    Package

    NDC 10135-0738-01 (10135073801)

    NDC Package Code 10135-738-01
    Billing NDC 10135073801
    Package 100 CAPSULE in 1 BOTTLE (10135-738-01)
    Marketing Start Date 2022-05-01
    NDC Exclude Flag N
    Pricing Information N/A