Search by Drug Name or NDC

    NDC 67544-0569-92 Oxybutynin Chloride 5 mg/1 Details

    Oxybutynin Chloride 5 mg/1

    Oxybutynin Chloride is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. The primary component is OXYBUTYNIN CHLORIDE.

    Product Information

    NDC 67544-0569
    Product ID 67544-569_7c8f8413-4c41-4f54-9530-46f64782ced0
    Associated GPIs 54100045200330
    GCN Sequence Number 004929
    GCN Sequence Number Description oxybutynin chloride TABLET 5 MG ORAL
    HIC3 R1A
    HIC3 Description URINARY TRACT ANTISPASMODIC/ANTIINCONTINENCE AGENT
    GCN 19380
    HICL Sequence Number 002048
    HICL Sequence Number Description OXYBUTYNIN CHLORIDE
    Brand/Generic Generic
    Proprietary Name Oxybutynin Chloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Oxybutynin Chloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 5
    Active Ingredient Units mg/1
    Substance Name OXYBUTYNIN CHLORIDE
    Labeler Name Aphena Pharma Solutions - Tennessee, LLC
    Pharmaceutical Class Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA071655
    Listing Certified Through 2024-12-31

    Package

    NDC 67544-0569-92 (67544056992)

    NDC Package Code 67544-569-92
    Billing NDC 67544056992
    Package 270 TABLET in 1 BOTTLE (67544-569-92)
    Marketing Start Date 2015-04-15
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL a16a5f0e-ae29-4b56-81a8-aa9398902a73 Details

    Revised: 2/2009