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    NDC 43547-0600-10 ropinirole hydrochloride 4 mg/1 Details

    ropinirole hydrochloride 4 mg/1

    ropinirole hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by SOLCO HEALTHCARE US, LLC. The primary component is ROPINIROLE HYDROCHLORIDE.

    Product Information

    NDC 43547-0600
    Product ID 43547-600_202c65a8-538f-4a87-853e-f86f9aa79905
    Associated GPIs 73203070100344
    GCN Sequence Number 043203
    GCN Sequence Number Description ropinirole HCl TABLET 4 MG ORAL
    HIC3 H6A
    HIC3 Description ANTIPARKINSONISM DRUGS,OTHER
    GCN 93038
    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 4
    Active Ingredient Units mg/1
    Substance Name ROPINIROLE HYDROCHLORIDE
    Labeler Name SOLCO HEALTHCARE US, LLC
    Pharmaceutical Class Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA078110
    Listing Certified Through 2024-12-31

    Package

    NDC 43547-0600-10 (43547060010)

    NDC Package Code 43547-600-10
    Billing NDC 43547060010
    Package 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-600-10)
    Marketing Start Date 2011-09-20
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 5823b3a2-3256-4d94-97b4-ec6b940312f4 Details

    Revised: 1/2022