NDC 0093-3609

Fluticasone Propionate and Salmeterol

Fluticasone Propionate And Salmeterol

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

Product ID0093-3609_0378204f-cc72-4a54-8ad7-ee9b93825261
NDC0093-3609
Product TypeHuman Prescription Drug
Proprietary NameFluticasone Propionate and Salmeterol
Generic NameFluticasone Propionate And Salmeterol
Dosage FormPowder, Metered
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2017-04-28
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA208799
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameFLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Active Ingredient Strength232 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 0093-3609-82

1 POUCH in 1 CARTON (0093-3609-82) > 1 INHALER in 1 POUCH > 60 POWDER, METERED in 1 INHALER
Marketing Start Date2017-04-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-3609-82 [00093360982]

Fluticasone Propionate and Salmeterol POWDER, METERED
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA208799
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-04-28

Drug Details

Active Ingredients

IngredientStrength
FLUTICASONE PROPIONATE232 ug/1

OpenFDA Data

SPL SET ID:43a27267-2f2b-410d-9c30-9cb95f35d9a1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1918203
  • 1918194
  • 1918209

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    50090-3387Fluticasone Propionate and SalmeterolFluticasone Propionate and Salmeterol
    50090-3271Fluticasone Propionate and SalmeterolFluticasone Propionate and Salmeterol
    50090-3272Fluticasone Propionate and SalmeterolFluticasone Propionate and Salmeterol
    0173-0695ADVAIRfluticasone propionate and salmeterol
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