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    NDC 63629-8289-01 Pramipexole Dihydrochloride 1 mg/1 Details

    Pramipexole Dihydrochloride 1 mg/1

    Pramipexole Dihydrochloride is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is PRAMIPEXOLE DIHYDROCHLORIDE.

    Product Information

    NDC 63629-8289
    Product ID 63629-8289_1ebb3e0b-8fd5-4ac8-ba2f-abfcfc0c91ad
    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 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 1
    Active Ingredient Units mg/1
    Substance Name PRAMIPEXOLE DIHYDROCHLORIDE
    Labeler Name Bryant Ranch Prepack
    Pharmaceutical Class Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA202633
    Listing Certified Through 2023-12-31

    Package

    NDC 63629-8289-01 (63629828901)

    NDC Package Code 63629-8289-1
    Billing NDC 63629828901
    Package 30 TABLET in 1 BOTTLE (63629-8289-1)
    Marketing Start Date 2020-01-10
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 1ebb3e0b-8fd5-4ac8-ba2f-abfcfc0c91ad Details

    Revised: 12/2021