NDC 50090-2404
Breo Ellipta
Fluticasone Furoate And Vilanterol Trifenatate
Breo Ellipta is a Respiratory (inhalation) Powder in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Fluticasone Furoate; Vilanterol Trifenatate.
| Product ID | 50090-2404_5b5dae35-bf7b-48f9-9e04-fa83ce96c135 |
| NDC | 50090-2404 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Breo Ellipta |
| Generic Name | Fluticasone Furoate And Vilanterol Trifenatate |
| Dosage Form | Powder |
| Route of Administration | RESPIRATORY (INHALATION) |
| Marketing Start Date | 2015-04-30 |
| Marketing Category | NDA / NDA |
| Application Number | NDA204275 |
| Labeler Name | A-S Medication Solutions |
| Substance Name | FLUTICASONE FUROATE; VILANTEROL TRIFENATATE |
| Active Ingredient Strength | 200 ug/1; ug/1 |
| Pharm Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
Packaging
NDC 50090-2404-0
1 TRAY in 1 CARTON (50090-2404-0) > 1 POWDER in 1 TRAY
| Marketing Start Date | 2016-05-17 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 50090-2404-0 [50090240400]
Breo Ellipta POWDER
| Marketing Category | NDA |
| Application Number | NDA204275 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-05-17 |
| Inactivation Date | 2020-01-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| FLUTICASONE FUROATE | 200 ug/1 |
OpenFDA Data
| SPL SET ID: | 2127c099-491a-4302-92aa-4747eb14b89a |
| Manufacturer | |
| UNII |
Pharmacological Class
- Corticosteroid [EPC]
- Corticosteroid Hormone Receptor Agonists [MoA]
- Adrenergic beta2-Agonists [MoA]
- beta2-Adrenergic Agonist [EPC]
NDC Crossover Matching brand name "Breo Ellipta" or generic name "Fluticasone Furoate And Vilanterol Trifenatate"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0173-0859 | Breo Ellipta | fluticasone furoate and vilanterol trifenatate |
| 0173-0882 | Breo Ellipta | fluticasone furoate and vilanterol trifenatate |
| 50090-2404 | Breo Ellipta | fluticasone furoate and vilanterol trifenatate |
| 70518-2028 | Breo Ellipta | fluticasone furoate and vilanterol trifenatate |
Trademark Results [Breo Ellipta]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BREO ELLIPTA 85826011 4502969 Live/Registered |
Glaxo Group Limited 2013-01-17 |
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