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NDC 00173-0916-10 Breo Ellipta 50; 25 ug/1; ug/1 Details
Breo Ellipta 50; 25 ug/1; ug/1
Breo Ellipta is a RESPIRATORY (INHALATION) POWDER in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by GlaxoSmithKline LLC. The primary component is FLUTICASONE FUROATE; VILANTEROL TRIFENATATE.
MedlinePlus Drug Summary
The combination of fluticasone and vilanterol is used to control wheezing, shortness of breath, coughing, and chest tightness caused by asthma and chronic obstructive pulmonary (COPD; a group of diseases that affect the lungs and airways, that includes chronic bronchitis and emphysema) in adults. It is also used to control difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by asthma in adults and children 5 years of age or older. Fluticasone is in a class of medications called steroids. It works by reducing swelling in the airways. Vilanterol is in a class of medications called long-acting beta-agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.
Related Packages: 00173-0916-10Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Fluticasone and Vilanterol Oral Inhalation
Product Information
| NDC | 00173-0916 |
|---|---|
| Product ID | 0173-0916_58e62ebe-a977-4ab7-b932-a2e985360dfb |
| Associated GPIs | |
| GCN Sequence Number | 085296 |
| GCN Sequence Number Description | fluticasone/vilanterol BLST W/DEV 50-25 MCG INHALATION |
| HIC3 | B63 |
| HIC3 Description | BETA-ADRENERGIC AND GLUCOCORTICOID COMBO, INHALED |
| GCN | 54747 |
| HICL Sequence Number | 040319 |
| HICL Sequence Number Description | FLUTICASONE FUROATE/VILANTEROL TRIFENATATE |
| Brand/Generic | Brand |
| Proprietary Name | Breo Ellipta |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | fluticasone furoate and vilanterol trifenatate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | POWDER |
| Route | RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 50; 25 |
| Active Ingredient Units | ug/1; ug/1 |
| Substance Name | FLUTICASONE FUROATE; VILANTEROL TRIFENATATE |
| Labeler Name | GlaxoSmithKline LLC |
| Pharmaceutical Class | Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA204275 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00173-0916-10 (00173091610)
| NDC Package Code | 0173-0916-10 |
|---|---|
| Billing NDC | 00173091610 |
| Package | 1 TRAY in 1 CARTON (0173-0916-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER |
| Marketing Start Date | 2023-05-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |