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    NDC 54288-0100-01 ZOLEDRONIC ACID 4 mg/5mL Details

    ZOLEDRONIC ACID 4 mg/5mL

    ZOLEDRONIC ACID is a INTRAVENOUS INJECTION, SOLUTION, CONCENTRATE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by BPI Labs, LLC. The primary component is ZOLEDRONIC ACID.

    Product Information

    NDC 54288-0100
    Product ID 54288-100_06f95c23-c908-982b-e063-6394a90a353f
    Associated GPIs 30042090001320
    GCN Sequence Number 051991
    GCN Sequence Number Description zoledronic acid VIAL 4 MG/5 ML INTRAVEN
    HIC3 P4L
    HIC3 Description BONE RESORPTION INHIBITORS
    GCN 19476
    HICL Sequence Number 021845
    HICL Sequence Number Description ZOLEDRONIC ACID
    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, CONCENTRATE
    Route INTRAVENOUS
    Active Ingredient Strength 4
    Active Ingredient Units mg/5mL
    Substance Name ZOLEDRONIC ACID
    Labeler Name BPI Labs, LLC
    Pharmaceutical Class Bisphosphonate [EPC], Diphosphonates [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA207341
    Listing Certified Through 2024-12-31

    Package

    NDC 54288-0100-01 (54288010001)

    NDC Package Code 54288-100-01
    Billing NDC 54288010001
    Package 1 VIAL in 1 CARTON (54288-100-01) / 5 mL in 1 VIAL
    Marketing Start Date 2018-04-02
    NDC Exclude Flag N
    Pricing Information N/A