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    NDC 67457-0794-10 Zoledronic Acid 5 mg/100mL Details

    Zoledronic Acid 5 mg/100mL

    Zoledronic Acid is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Institutional LLC. The primary component is ZOLEDRONIC ACID.

    Product Information

    NDC 67457-0794
    Product ID 67457-794_56262420-3c78-4c82-af48-d5aad6b5de4a
    Associated GPIs 30042090002020
    GCN Sequence Number 070632
    GCN Sequence Number Description zoledronic acid/mannitol-water PIGGYBACK 5 MG/100ML INTRAVEN
    HIC3 P4L
    HIC3 Description BONE RESORPTION INHIBITORS
    GCN 34228
    HICL Sequence Number 034717
    HICL Sequence Number Description ZOLEDRONIC ACID IN MANNITOL AND WATER FOR INJECTION
    Brand/Generic Generic
    Proprietary Name Zoledronic Acid
    Proprietary Name Suffix n/a
    Non-Proprietary Name Zoledronic Acid
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 5
    Active Ingredient Units mg/100mL
    Substance Name ZOLEDRONIC ACID
    Labeler Name Mylan Institutional LLC
    Pharmaceutical Class Bisphosphonate [EPC], Diphosphonates [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA205254
    Listing Certified Through 2024-12-31

    Package

    NDC 67457-0794-10 (67457079410)

    NDC Package Code 67457-794-10
    Billing NDC 67457079410
    Package 1 BAG in 1 POUCH (67457-794-10) / 100 mL in 1 BAG
    Marketing Start Date 2018-06-05
    NDC Exclude Flag N
    Pricing Information N/A