NDC 70518-2501

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 Remedyrepack Inc.. The primary component is Fluticasone Propionate; Salmeterol Xinafoate.

Product ID70518-2501_9a580325-d8c1-2e9c-e053-2a95a90acd14
NDC70518-2501
Product TypeHuman Prescription Drug
Proprietary NameWixela Inhub
Generic NameFluticasone Propionate And Salmeterol
Dosage FormPowder
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2019-12-19
Marketing CategoryANDA / ANDA
Application NumberANDA208891
Labeler NameREMEDYREPACK INC.
Substance NameFLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Active Ingredient Strength250 ug/1; ug/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-2501-0

1 INHALER in 1 CARTON (70518-2501-0) > 60 POWDER in 1 INHALER
Marketing Start Date2019-12-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-2501-0 [70518250100]

Wixela Inhub POWDER
Marketing CategoryANDA
Application NumberANDA208891
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-19

Drug Details

Active Ingredients

IngredientStrength
FLUTICASONE PROPIONATE250 ug/1

OpenFDA Data

SPL SET ID:8eb3083e-11c2-4272-8adc-4b7fbbfc0483
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 896209
  • 2110513

    • Pharmacological Class

    • 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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