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    NDC 63629-4798-05 ropinirole hydrochloride 0.5 mg/1 Details

    ropinirole hydrochloride 0.5 mg/1

    ropinirole hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is ROPINIROLE HYDROCHLORIDE.

    Product Information

    NDC 63629-4798
    Product ID 63629-4798_a77fe0b5-6a7f-413e-a6c9-952a1b2b1506
    Associated GPIs
    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 ropinirole hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name ropinirole hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 0.5
    Active Ingredient Units mg/1
    Substance Name ROPINIROLE HYDROCHLORIDE
    Labeler Name Bryant Ranch Prepack
    Pharmaceutical Class Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA078110
    Listing Certified Through 2023-12-31

    Package

    NDC 63629-4798-05 (63629479805)

    NDC Package Code 63629-4798-5
    Billing NDC 63629479805
    Package 100 TABLET, FILM COATED in 1 BOTTLE (63629-4798-5)
    Marketing Start Date 2018-02-28
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 8e23aac9-446c-43b5-89ab-fc596b766df0 Details

    Revised: 4/2022