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    NDC 60505-4317-03 tolvaptan 15 mg/1 Details

    tolvaptan 15 mg/1

    tolvaptan is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Apotex Corp.. The primary component is TOLVAPTAN.

    Product Information

    NDC 60505-4317
    Product ID 60505-4317_4c608abc-bf94-af08-1ad9-04d18d633ae2
    Associated GPIs
    GCN Sequence Number 065227
    GCN Sequence Number Description tolvaptan TABLET 15 MG ORAL
    HIC3 R1N
    HIC3 Description ARGININE VASOPRESSIN (AVP) RECEPTOR ANTAGONISTS
    GCN 24294
    HICL Sequence Number 036348
    HICL Sequence Number Description TOLVAPTAN
    Brand/Generic Generic
    Proprietary Name tolvaptan
    Proprietary Name Suffix n/a
    Non-Proprietary Name tolvaptan
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 15
    Active Ingredient Units mg/1
    Substance Name TOLVAPTAN
    Labeler Name Apotex Corp.
    Pharmaceutical Class Vasopressin V2 Receptor Antagonist [EPC], Vasopressin V2 Receptor Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA207605
    Listing Certified Through 2024-12-31

    Package

    NDC 60505-4317-03 (60505431703)

    NDC Package Code 60505-4317-3
    Billing NDC 60505431703
    Package 30 TABLET in 1 BOTTLE (60505-4317-3)
    Marketing Start Date 2022-12-14
    NDC Exclude Flag N
    Pricing Information N/A