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    NDC 71205-0868-78 Ranolazine 1000 mg/1 Details

    Ranolazine 1000 mg/1

    Ranolazine is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is RANOLAZINE.

    Product Information

    NDC 71205-0868
    Product ID 71205-868_278d3fa3-3304-43dc-8a2a-a463c8ae9e9d
    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, FILM COATED, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 1000
    Active Ingredient Units mg/1
    Substance Name RANOLAZINE
    Labeler Name Proficient Rx LP
    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 ANDA211829
    Listing Certified Through 2024-12-31

    Package

    NDC 71205-0868-78 (71205086878)

    NDC Package Code 71205-868-78
    Billing NDC 71205086878
    Package 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-868-78)
    Marketing Start Date 2021-12-17
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 989e1688-a0b5-4297-bf91-234de2a0b445 Details

    Revised: 3/2022