Search by Drug Name or NDC

    NDC 68083-0615-01 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 Gland Pharma Limited. The primary component is ZOLEDRONIC ACID.

    Product Information

    NDC 68083-0615
    Product ID 68083-615_c08f4eee-1566-4493-83f7-48fa1319a234
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    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 Gland Pharma Limited
    Pharmaceutical Class Bisphosphonate [EPC], Diphosphonates [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA202930
    Listing Certified Through 2024-12-31

    Package

    NDC 68083-0615-01 (68083061501)

    NDC Package Code 68083-615-01
    Billing NDC 68083061501
    Package 1 VIAL, GLASS in 1 CARTON (68083-615-01) / 5 mL in 1 VIAL, GLASS
    Marketing Start Date 2023-11-08
    NDC Exclude Flag N
    Pricing Information N/A