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    NDC 49884-0058-02 Bosentan 62.5 mg/1 Details

    Bosentan 62.5 mg/1

    Bosentan is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Par Pharmaceutical, Inc.. The primary component is BOSENTAN.

    Product Information

    NDC 49884-0058
    Product ID 49884-058_f84703d1-3078-4784-801d-35d80f416a3b
    Associated GPIs 40160015000320
    GCN Sequence Number 048988
    GCN Sequence Number Description bosentan TABLET 62.5 MG ORAL
    HIC3 B1B
    HIC3 Description PULMONARY ANTI-HTN, ENDOTHELIN RECEPTOR ANTAGONIST
    GCN 14979
    HICL Sequence Number 022990
    HICL Sequence Number Description BOSENTAN
    Brand/Generic Generic
    Proprietary Name Bosentan
    Proprietary Name Suffix n/a
    Non-Proprietary Name Bosentan
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 62.5
    Active Ingredient Units mg/1
    Substance Name BOSENTAN
    Labeler Name Par Pharmaceutical, Inc.
    Pharmaceutical Class Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA205699
    Listing Certified Through 2023-12-31

    Package

    NDC 49884-0058-02 (49884005802)

    NDC Package Code 49884-058-02
    Billing NDC 49884005802
    Package 60 TABLET, FILM COATED in 1 CONTAINER (49884-058-02)
    Marketing Start Date 2019-04-29
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL ec445d89-6b19-47b2-aadf-8f65134e4344 Details

    Revised: 3/2022