NDC 63402-510

Xopenex HFA

Levalbuterol Tartrate

Xopenex HFA is a Oral Aerosol, Metered in the Human Prescription Drug category. It is labeled and distributed by Sunovion Pharmaceuticals Inc.. The primary component is Levalbuterol Tartrate.

Product ID63402-510_93390d71-9fb2-497a-a1b6-b1ce6178430c
NDC63402-510
Product TypeHuman Prescription Drug
Proprietary NameXopenex HFA
Generic NameLevalbuterol Tartrate
Dosage FormAerosol, Metered
Route of AdministrationORAL
Marketing Start Date2005-12-01
Marketing CategoryNDA / NDA
Application NumberNDA021730
Labeler NameSunovion Pharmaceuticals Inc.
Substance NameLEVALBUTEROL TARTRATE
Active Ingredient Strength45 ug/1
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63402-510-01

1 INHALER in 1 CARTON (63402-510-01) > 200 AEROSOL, METERED in 1 INHALER
Marketing Start Date2005-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63402-510-01 [63402051001]

Xopenex HFA AEROSOL, METERED
Marketing CategoryNDA
Application NumberNDA021730
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2005-12-01

NDC 63402-510-04 [63402051004]

Xopenex HFA AEROSOL, METERED
Marketing CategoryNDA
Application NumberNDA021730
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-04-01
Marketing End Date2008-04-01

NDC 63402-510-05 [63402051005]

Xopenex HFA AEROSOL, METERED
Marketing CategoryNDA
Application NumberNDA021730
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-06-11
Marketing End Date2011-12-22

NDC 63402-510-03 [63402051003]

Xopenex HFA AEROSOL, METERED
Marketing CategoryNDA
Application NumberNDA021730
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-04-01
Marketing End Date2015-02-28

Drug Details

Active Ingredients

IngredientStrength
LEVALBUTEROL TARTRATE45 ug/1

OpenFDA Data

SPL SET ID:218ab3f0-4d1e-4c33-a7e8-27807f029d83
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 996233
  • 996232
  • 745791
  • 746466
    • UPC Code
  • 0363402510011

    • Pharmacological Class

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

    Medicade Reported Pricing

    63402051001 XOPENEX HFA 45 MCG INHALER

    Pricing Unit: GM | Drug Type:

    NDC Crossover Matching brand name "Xopenex HFA" or generic name "Levalbuterol Tartrate"

    NDCBrand NameGeneric Name
    63402-510Xopenex HFAlevalbuterol tartrate
    0591-2927Levalbuterol tartrate HFA inhalationlevalbuterol tartrate
    63187-876Levalbuterol tartrate HFA inhalationlevalbuterol tartrate
    63629-8822Levalbuterol tartrate HFA inhalationlevalbuterol tartrate
    68788-6845Levalbuterol tartrate HFA inhalationlevalbuterol tartrate

    Trademark Results [Xopenex HFA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XOPENEX HFA
    XOPENEX HFA
    78333582 3124312 Live/Registered
    SUNOVION PHARMACEUTICALS INC.
    2003-11-26
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