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    NDC 69097-0318-53 Budesonide 0.25 mg/2mL Details

    Budesonide 0.25 mg/2mL

    Budesonide is a ORAL INHALANT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Cipla USA Inc.. The primary component is BUDESONIDE.

    Product Information

    NDC 69097-0318
    Product ID 69097-318_87894b75-a8c5-4d48-81bd-5ad43d66afc3
    Associated GPIs 44400015001830
    GCN Sequence Number 046525
    GCN Sequence Number Description budesonide AMPUL-NEB 0.25MG/2ML INHALATION
    HIC3 B6M
    HIC3 Description GLUCOCORTICOIDS, ORALLY INHALED
    GCN 17957
    HICL Sequence Number 006545
    HICL Sequence Number Description BUDESONIDE
    Brand/Generic Generic
    Proprietary Name Budesonide
    Proprietary Name Suffix Inhalation Suspension
    Non-Proprietary Name Budesonide
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INHALANT
    Route ORAL
    Active Ingredient Strength 0.25
    Active Ingredient Units mg/2mL
    Substance Name BUDESONIDE
    Labeler Name Cipla USA Inc.
    Pharmaceutical Class Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA205710
    Listing Certified Through 2024-12-31

    Package

    NDC 69097-0318-53 (69097031853)

    NDC Package Code 69097-318-53
    Billing NDC 69097031853
    Package 30 POUCH in 1 CARTON (69097-318-53) / 1 AMPULE in 1 POUCH (69097-318-32) / 2 mL in 1 AMPULE
    Marketing Start Date 2020-10-15
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 0.67982
    Pricing Unit ML
    Effective Date 2022-11-23
    NDC Description BUDESONIDE 0.25 MG/2 ML SUSP
    Pharmacy Type Indicator C/I
    OTC N
    Explanation Code 1, 5
    Classification for Rate Setting G
    As of Date 2022-11-23
    This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

    Standard Product Labeling (SPL)/Prescribing Information SPL c52c5382-1400-44b9-95be-a30e1cf706da Details

    Revised: 12/2021