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    NDC 00409-1401-01 Regadenoson 0.08 mg/mL Details

    Regadenoson 0.08 mg/mL

    Regadenoson is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hospira, Inc.. The primary component is REGADENOSON ANHYDROUS.

    Product Information

    NDC 00409-1401
    Product ID 0409-1401_5216c6a9-392e-4f73-8d03-3defdffcff10
    Associated GPIs
    GCN Sequence Number 064044
    GCN Sequence Number Description regadenoson SYRINGE 0.4 MG/5ML INTRAVEN
    HIC3 A6V
    HIC3 Description CARDIOVASCULAR DIAGNOSTICS,NON-RADIOPAQUE AGENTS
    GCN 99755
    HICL Sequence Number 035625
    HICL Sequence Number Description REGADENOSON
    Brand/Generic Generic
    Proprietary Name Regadenoson
    Proprietary Name Suffix n/a
    Non-Proprietary Name Regadenoson
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 0.08
    Active Ingredient Units mg/mL
    Substance Name REGADENOSON ANHYDROUS
    Labeler Name Hospira, Inc.
    Pharmaceutical Class Adenosine Receptor Agonists [MoA], Pharmacologic Cardiac Stress Test Agent [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA214349
    Listing Certified Through 2024-12-31

    Package

    NDC 00409-1401-01 (00409140101)

    NDC Package Code 0409-1401-01
    Billing NDC 00409140101
    Package 10 CARTON in 1 PACKAGE (0409-1401-01) / 1 SYRINGE, PLASTIC in 1 CARTON / 5 mL in 1 SYRINGE, PLASTIC (0409-1401-05)
    Marketing Start Date 2023-03-01
    NDC Exclude Flag N
    Pricing Information N/A