NDC 17478-171

Xopenex

Levalbuterol Hydrochloride

Xopenex is a Respiratory (inhalation) Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Akorn, Inc.. The primary component is Levalbuterol Hydrochloride.

Product ID17478-171_2d495cb9-f9e7-4069-9d7f-c4c664bcaf40
NDC17478-171
Product TypeHuman Prescription Drug
Proprietary NameXopenex
Generic NameLevalbuterol Hydrochloride
Dosage FormSolution, Concentrate
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2015-02-26
Marketing CategoryNDA / NDA
Application NumberNDA020837
Labeler NameAkorn, Inc.
Substance NameLEVALBUTEROL HYDROCHLORIDE
Active Ingredient Strength1 mg/.5mL
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 17478-171-30

30 POUCH in 1 CARTON (17478-171-30) > 1 VIAL, SINGLE-DOSE in 1 POUCH (17478-171-01) > .5 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2015-02-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17478-171-01 [17478017101]

Xopenex SOLUTION, CONCENTRATE
Marketing CategoryNDA
Application NumberNDA020837
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-02-26

NDC 17478-171-30 [17478017130]

Xopenex SOLUTION, CONCENTRATE
Marketing CategoryNDA
Application NumberNDA020837
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-02-26

Drug Details

Active Ingredients

IngredientStrength
LEVALBUTEROL HYDROCHLORIDE1.25 mg/.5mL

OpenFDA Data

SPL SET ID:0c47c47d-45f7-4eb4-b1f8-7d6c633a1f69
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1855391
  • 1855389
    • UPC Code
  • 0317478171010

    • Pharmacological Class

    • Adrenergic beta2-Agonists [MoA]
    • beta2-Adrenergic Agonist [EPC]
    • Adrenergic beta2-Agonists [MoA]
    • beta2-Adrenergic Agonist [EPC]

    NDC Crossover Matching brand name "Xopenex" or generic name "Levalbuterol Hydrochloride"

    NDCBrand NameGeneric Name
    17478-171XopenexLevalbuterol Hydrochloride
    17478-172XopenexLevalbuterol Hydrochloride
    17478-173XopenexLevalbuterol Hydrochloride
    17478-174XopenexLevalbuterol Hydrochloride
    21695-153Xopenexlevalbuterol hydrochloride
    70518-1227XopenexXopenex
    0115-9930LevalbuterolLevalbuterol Hydrochloride
    0115-9931LevalbuterolLevalbuterol Hydrochloride
    0115-9932LevalbuterolLevalbuterol Hydrochloride
    35573-443LevalbuterolLevalbuterol Hydrochloride
    35573-444LevalbuterolLevalbuterol Hydrochloride
    35573-445LevalbuterolLevalbuterol Hydrochloride
    66993-021Levalbuterol HydrochlorideLevalbuterol Hydrochloride
    66993-022Levalbuterol HydrochlorideLevalbuterol Hydrochloride
    66993-023Levalbuterol HydrochlorideLevalbuterol Hydrochloride

    Trademark Results [Xopenex]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XOPENEX
    XOPENEX
    77138209 3655211 Live/Registered
    SUNOVION PHARMACEUTICALS INC.
    2007-03-22
    XOPENEX
    XOPENEX
    77138201 3651698 Live/Registered
    SUNOVION PHARMACEUTICALS INC.
    2007-03-22
    XOPENEX
    XOPENEX
    75468045 2350721 Live/Registered
    SUNOVION PHARMACEUTICALS INC.
    1998-04-14
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