NDC 21695-153

Xopenex

Levalbuterol Hydrochloride

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

Product ID21695-153_35eb525b-72a5-4ef9-a36a-531e9e6b3560
NDC21695-153
Product TypeHuman Prescription Drug
Proprietary NameXopenex
Generic NameLevalbuterol Hydrochloride
Dosage FormSolution
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date1999-04-01
Marketing CategoryNDA / NDA
Application NumberNDA020837
Labeler NameRebel Distributors Corp
Substance NameLEVALBUTEROL HYDROCHLORIDE
Active Ingredient Strength1 mg/3mL
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-153-24

2 POUCH in 1 CARTON (21695-153-24) > 12 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date1999-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-153-24 [21695015324]

Xopenex SOLUTION
Marketing CategoryNDA
Application NumberNDA020837
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1999-04-01
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
LEVALBUTEROL HYDROCHLORIDE1.25 mg/3mL

OpenFDA Data

SPL SET ID:35eb525b-72a5-4ef9-a36a-531e9e6b3560
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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