NDC 0378-9322

Wixela Inhub

Fluticasone Propionate And Salmeterol

Wixela Inhub is a Respiratory (inhalation) Powder in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Fluticasone Propionate; Salmeterol Xinafoate.

Product ID0378-9322_03d33612-03b4-4a2c-ba86-47816db363ce
NDC0378-9322
Product TypeHuman Prescription Drug
Proprietary NameWixela Inhub
Generic NameFluticasone Propionate And Salmeterol
Dosage FormPowder
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2019-02-11
Marketing CategoryANDA / ANDA
Application NumberANDA208891
Labeler NameMylan Pharmaceuticals Inc.
Substance NameFLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Active Ingredient Strength500 ug/1; ug/1
Pharm ClassesAdrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0378-9322-32

1 INHALER in 1 CARTON (0378-9322-32) > 60 POWDER in 1 INHALER
Marketing Start Date2019-02-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-9322-32 [00378932232]

Wixela Inhub POWDER
Marketing CategoryANDA
Application NumberANDA208891
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-11

Drug Details

Active Ingredients

IngredientStrength
FLUTICASONE PROPIONATE500 ug/1

OpenFDA Data

SPL SET ID:3beef422-8a07-4a45-9ba6-414511e4b7e2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2110510
  • 2110513
  • 2110516
  • 896209
  • 896228
  • 896184

    • Pharmacological Class

    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]
    • Adrenergic beta2-Agonists [MoA]
    • beta2-Adrenergic Agonist [EPC]
    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]
    • Adrenergic beta2-Agonists [MoA]
    • beta2-Adrenergic Agonist [EPC]

    NDC Crossover Matching brand name "Wixela Inhub" or generic name "Fluticasone Propionate And Salmeterol"

    NDCBrand NameGeneric Name
    0378-9321Wixela InhubWixela Inhub
    0378-9320Wixela InhubWixela Inhub
    0378-9322Wixela InhubWixela Inhub
    70518-2501Wixela InhubWixela Inhub
    0173-0695ADVAIRfluticasone propionate and salmeterol
    0054-0326fluticasone propionate and salmeterolfluticasone propionate and salmeterol
    0054-0327fluticasone propionate and salmeterolfluticasone propionate and salmeterol
    0093-3607Fluticasone Propionate and SalmeterolFluticasone Propionate and Salmeterol
    0093-3608Fluticasone Propionate and SalmeterolFluticasone Propionate and Salmeterol
    0093-3609Fluticasone Propionate and SalmeterolFluticasone Propionate and Salmeterol
    0093-7516fluticasone propionate and salmeterolfluticasone propionate and salmeterol
    0093-7517fluticasone propionate and salmeterolfluticasone propionate and salmeterol
    0093-7518fluticasone propionate and salmeterolfluticasone propionate and salmeterol

    Trademark Results [Wixela Inhub]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    WIXELA INHUB
    WIXELA INHUB
    88294741 5821913 Live/Registered
    Mylan Pharmaceuticals, Inc.
    2019-02-08
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