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    NDC 61919-0564-30 ROPINIROLE HYDROCHLORIDE 0.25 mg/1 Details

    ROPINIROLE HYDROCHLORIDE 0.25 mg/1

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

    Product Information

    NDC 61919-0564
    Product ID 61919-564_cc0df9b3-16e9-d642-e053-2a95a90a7726
    Associated GPIs 73203070100310
    GCN Sequence Number 029159
    GCN Sequence Number Description ropinirole HCl TABLET 0.25 MG ORAL
    HIC3 H6A
    HIC3 Description ANTIPARKINSONISM DRUGS,OTHER
    GCN 34100
    HICL Sequence Number 012182
    HICL Sequence Number Description ROPINIROLE HCL
    Brand/Generic Generic
    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 0.25
    Active Ingredient Units mg/1
    Substance Name ROPINIROLE HYDROCHLORIDE
    Labeler Name Direct_Rx
    Pharmaceutical Class Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA090429
    Listing Certified Through 2023-12-31

    Package

    NDC 61919-0564-30 (61919056430)

    NDC Package Code 61919-564-30
    Billing NDC 61919056430
    Package 30 TABLET, FILM COATED in 1 BOTTLE (61919-564-30)
    Marketing Start Date 2021-09-15
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 7f6bf28c-d6bd-169a-e053-2991aa0a4664 Details

    Revised: 9/2021