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    NDC 13925-0522-01 Pentamidine Isethionate 300 mg/300mg Details

    Pentamidine Isethionate 300 mg/300mg

    Pentamidine Isethionate is a RESPIRATORY (INHALATION) INHALANT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Seton Pharmaceuticals. The primary component is PENTAMIDINE ISETHIONATE.

    Product Information

    NDC 13925-0522
    Product ID 13925-522_cfac4bb5-52dc-46ae-9a66-a47d745ed852
    Associated GPIs 16000045002170
    GCN Sequence Number 011791
    GCN Sequence Number Description pentamidine isethionate VIAL-NEB 300 MG INHALATION
    HIC3 W4K
    HIC3 Description ANTIPROTOZOAL DRUGS,MISCELLANEOUS
    GCN 42980
    HICL Sequence Number 004162
    HICL Sequence Number Description PENTAMIDINE ISETHIONATE
    Brand/Generic Generic
    Proprietary Name Pentamidine Isethionate
    Proprietary Name Suffix n/a
    Non-Proprietary Name Pentamidine Isethionate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INHALANT
    Route RESPIRATORY (INHALATION)
    Active Ingredient Strength 300
    Active Ingredient Units mg/300mg
    Substance Name PENTAMIDINE ISETHIONATE
    Labeler Name Seton Pharmaceuticals
    Pharmaceutical Class Antiprotozoal [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA206667
    Listing Certified Through 2024-12-31

    Package

    NDC 13925-0522-01 (13925052201)

    NDC Package Code 13925-522-01
    Billing NDC 13925052201
    Package 1 VIAL in 1 CARTON (13925-522-01) / 300 mg in 1 VIAL
    Marketing Start Date 2019-10-14
    NDC Exclude Flag N
    Pricing Information N/A