Search by Drug Name or NDC

    NDC 72789-0034-12 Ondansetron Hydrochloride 4 mg/1 Details

    Ondansetron Hydrochloride 4 mg/1

    Ondansetron Hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PD-Rx Pharmaceuticals, Inc.. The primary component is ONDANSETRON HYDROCHLORIDE.

    Product Information

    NDC 72789-0034
    Product ID 72789-034_f8874fd6-9a6c-c6b9-e053-6294a90afb7d
    Associated GPIs 50250065050310
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name Ondansetron Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Ondansetron Hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 4
    Active Ingredient Units mg/1
    Substance Name ONDANSETRON HYDROCHLORIDE
    Labeler Name PD-Rx Pharmaceuticals, Inc.
    Pharmaceutical Class Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA078539
    Listing Certified Through 2024-12-31

    Package

    NDC 72789-0034-12 (72789003412)

    NDC Package Code 72789-034-12
    Billing NDC 72789003412
    Package 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-034-12)
    Marketing Start Date 2019-12-02
    NDC Exclude Flag N
    Pricing Information N/A