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    NDC 72578-0065-05 Ranolazine 1000 mg/1 Details

    Ranolazine 1000 mg/1

    Ranolazine is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Viona Pharmaceuticals Inc. The primary component is RANOLAZINE.

    Product Information

    NDC 72578-0065
    Product ID 72578-065_2c72dbc3-5385-4706-b5fd-841d4b70a26f
    Associated GPIs 32200040007430
    GCN Sequence Number 062973
    GCN Sequence Number Description ranolazine TAB ER 12H 1000 MG ORAL
    HIC3 A2C
    HIC3 Description ANTIANGINAL, ANTI-ISCHEMIC AGENTS,NON-HEMODYNAMIC
    GCN 98733
    HICL Sequence Number 033446
    HICL Sequence Number Description RANOLAZINE
    Brand/Generic Generic
    Proprietary Name Ranolazine
    Proprietary Name Suffix n/a
    Non-Proprietary Name Ranolazine
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 1000
    Active Ingredient Units mg/1
    Substance Name RANOLAZINE
    Labeler Name Viona Pharmaceuticals Inc
    Pharmaceutical Class Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA210188
    Listing Certified Through 2024-12-31

    Package

    NDC 72578-0065-05 (72578006505)

    NDC Package Code 72578-065-05
    Billing NDC 72578006505
    Package 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-065-05)
    Marketing Start Date 2019-09-10
    NDC Exclude Flag N
    Pricing Information N/A