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    NDC 76204-0700-01 Levalbuterol 0.31 mg/3mL Details

    Levalbuterol 0.31 mg/3mL

    Levalbuterol is a RESPIRATORY (INHALATION) SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Ritedose Pharmaceuticals, LLC. The primary component is LEVALBUTEROL HYDROCHLORIDE.

    Product Information

    NDC 76204-0700
    Product ID 76204-700_0cf37834-6265-6135-e063-6294a90a2bfd
    Associated GPIs 44201045102510
    GCN Sequence Number 049871
    GCN Sequence Number Description levalbuterol HCl VIAL-NEB 0.31MG/3ML INHALATION
    HIC3 B6W
    HIC3 Description BETA-ADRENERGIC AGENTS, INHALED, SHORT ACTING
    GCN 15665
    HICL Sequence Number 019858
    HICL Sequence Number Description LEVALBUTEROL HCL
    Brand/Generic Generic
    Proprietary Name Levalbuterol
    Proprietary Name Suffix n/a
    Non-Proprietary Name Levalbuterol Hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SOLUTION
    Route RESPIRATORY (INHALATION)
    Active Ingredient Strength 0.31
    Active Ingredient Units mg/3mL
    Substance Name LEVALBUTEROL HYDROCHLORIDE
    Labeler Name Ritedose Pharmaceuticals, LLC
    Pharmaceutical Class Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA203653
    Listing Certified Through 2024-12-31

    Package

    NDC 76204-0700-01 (76204070001)

    NDC Package Code 76204-700-01
    Billing NDC 76204070001
    Package 30 POUCH in 1 CARTON (76204-700-01) / 1 AMPULE in 1 POUCH (76204-700-11) / 3 mL in 1 AMPULE
    Marketing Start Date 2017-02-17
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 0.33132
    Pricing Unit ML
    Effective Date 2023-06-21
    NDC Description LEVALBUTEROL 0.31 MG/3 ML SOL
    Pharmacy Type Indicator C/I
    OTC N
    Explanation Code 4, 5
    Classification for Rate Setting G
    As of Date 2024-02-21
    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