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    NDC 65862-0604-99 Pramipexole Dihydrochloride 0.125 mg/1 Details

    Pramipexole Dihydrochloride 0.125 mg/1

    Pramipexole Dihydrochloride is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is PRAMIPEXOLE DIHYDROCHLORIDE.

    Product Information

    NDC 65862-0604
    Product ID 65862-604_6a54f410-0fc1-4e7d-a7d4-0f3c71d5fb79
    Associated GPIs 73203060100305
    GCN Sequence Number 031781
    GCN Sequence Number Description pramipexole di-HCl TABLET 0.125 MG ORAL
    HIC3 H6A
    HIC3 Description ANTIPARKINSONISM DRUGS,OTHER
    GCN 19873
    HICL Sequence Number 013455
    HICL Sequence Number Description PRAMIPEXOLE DI-HCL
    Brand/Generic Generic
    Proprietary Name Pramipexole Dihydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Pramipexole Dihydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 0.125
    Active Ingredient Units mg/1
    Substance Name PRAMIPEXOLE DIHYDROCHLORIDE
    Labeler Name Aurobindo Pharma Limited
    Pharmaceutical Class Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA202633
    Listing Certified Through 2024-12-31

    Package

    NDC 65862-0604-99 (65862060499)

    NDC Package Code 65862-604-99
    Billing NDC 65862060499
    Package 1000 TABLET in 1 BOTTLE (65862-604-99)
    Marketing Start Date 2012-10-26
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 3f90971a-e005-4dd3-bb93-b09125ada3c8 Details

    Revised: 7/2021