NDC 0093-3607

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 ID: 0093-3607_0378204f-cc72-4a54-8ad7-ee9b93825261
• NDC: 0093-3607
• Product Type: Human Prescription Drug
• Proprietary Name: Fluticasone Propionate and Salmeterol
• Generic Name: Fluticasone Propionate And Salmeterol
• Dosage Form: Powder, Metered
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 2017-04-28
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA208799
• Labeler Name: Teva Pharmaceuticals USA, Inc.
• Substance Name: FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
• Active Ingredient Strength: 55 ug/1; ug/1
• Pharm Classes: Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0093-3607-82

1 POUCH in 1 CARTON (0093-3607-82) > 1 INHALER in 1 POUCH > 60 POWDER, METERED in 1 INHALER

• Marketing Start Date: 2017-04-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0093-3607-82 [00093360782]

Fluticasone Propionate and Salmeterol POWDER, METERED

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA208799
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-04-28

Drug Details

Active Ingredients

Ingredient	Strength
FLUTICASONE PROPIONATE	55 ug/1

OpenFDA Data

• SPL SET ID: 43a27267-2f2b-410d-9c30-9cb95f35d9a1
• Manufacturer:
  • Teva Pharmaceuticals USA, Inc.
• UNII:
  • O2GMZ0LF5W
  • 6EW8Q962A5
• 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"

NDC	Brand Name	Generic Name
0054-0326	fluticasone propionate and salmeterol	fluticasone propionate and salmeterol
0054-0327	fluticasone propionate and salmeterol	fluticasone propionate and salmeterol
0093-3607	Fluticasone Propionate and Salmeterol	Fluticasone Propionate and Salmeterol
0093-3608	Fluticasone Propionate and Salmeterol	Fluticasone Propionate and Salmeterol
0093-3609	Fluticasone Propionate and Salmeterol	Fluticasone Propionate and Salmeterol
0093-7516	fluticasone propionate and salmeterol	fluticasone propionate and salmeterol
0093-7517	fluticasone propionate and salmeterol	fluticasone propionate and salmeterol
0093-7518	fluticasone propionate and salmeterol	fluticasone propionate and salmeterol
50090-3387	Fluticasone Propionate and Salmeterol	Fluticasone Propionate and Salmeterol
50090-3271	Fluticasone Propionate and Salmeterol	Fluticasone Propionate and Salmeterol
50090-3272	Fluticasone Propionate and Salmeterol	Fluticasone Propionate and Salmeterol
0173-0695	ADVAIR	fluticasone propionate and salmeterol