NDC 70518-1227

Xopenex

Levalbuterol Hydrochloride

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

Product ID70518-1227_6fbd6fa1-4611-a5e3-e053-2991aa0a3c29
NDC70518-1227
Product TypeHuman Prescription Drug
Proprietary NameXopenex
Generic NameLevalbuterol Hydrochloride
Dosage FormSolution
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2018-05-25
Marketing CategoryNDA / NDA
Application NumberNDA020837
Labeler NameREMEDYREPACK INC.
Substance NameLEVALBUTEROL HYDROCHLORIDE
Active Ingredient Strength1 mg/3mL
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-1227-0

2 POUCH in 1 CARTON (70518-1227-0) > 12 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-05-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1227-0 [70518122700]

Xopenex SOLUTION
Marketing CategoryNDA
Application NumberNDA020837
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-25
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
LEVALBUTEROL HYDROCHLORIDE1.25 mg/3mL

OpenFDA Data

SPL SET ID:13ca98a1-dcef-4358-b636-6be445483ae2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 833470
  • 242754

    • Pharmacological Class

    • 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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