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    NDC 63323-0966-00 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 Fresenius Kabi USA, LLC. The primary component is ZOLEDRONIC ACID.

    Product Information

    NDC 63323-0966
    Product ID 63323-966_9fb5ae91-44b4-4b48-aaeb-0a2ba676aa16
    Associated GPIs 30042090002020
    GCN Sequence Number 059404
    GCN Sequence Number Description zoledronic acid/mannitol-water PGGYBK BTL 5 MG/100ML INTRAVEN
    HIC3 P4L
    HIC3 Description BONE RESORPTION INHIBITORS
    GCN 25026
    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 Fresenius Kabi USA, LLC
    Pharmaceutical Class Bisphosphonate [EPC], Diphosphonates [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA204217
    Listing Certified Through 2024-12-31

    Package

    NDC 63323-0966-00 (63323096600)

    NDC Package Code 63323-966-00
    Billing NDC 63323096600
    Package 1 VIAL, GLASS in 1 CARTON (63323-966-00) / 100 mL in 1 VIAL, GLASS
    Marketing Start Date 2017-02-17
    NDC Exclude Flag N
    Pricing Information N/A