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NDC 00173-0893-61 Trelegy Ellipta 200; 62.5; 25 ug/1; ug/1; ug/1 Details
Trelegy Ellipta 200; 62.5; 25 ug/1; ug/1; ug/1
Trelegy 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; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE.
MedlinePlus Drug Summary
The combination of fluticasone, umeclidinium, and vilanterol is used to control wheezing, shortness of breath, coughing, and chest tightness caused by chronic obstructive pulmonary (COPD; a group of diseases that affect the lungs and airways, that includes chronic bronchitis and emphysema). It is also used in adults to control wheezing, shortness of breath, coughing, and chest tightness caused by asthma. Fluticasone is in a class of medications called steroids. Umeclidinium is in a class of medication called anticholinergics. Vilanterol is in a class of medications called long-acting beta-agonists (LABAs). The combination of fluticasone, umeclidinium, and vilanterol works by relaxing and opening air passages in the lungs, making it easier to breathe.
Related Packages: 00173-0893-61Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation
Product Information
| NDC | 00173-0893 |
|---|---|
| Product ID | 0173-0893_d6db0c6b-fa8c-4b68-9ce1-76cac0c042c5 |
| Associated GPIs | 44209903408040 |
| GCN Sequence Number | 081555 |
| GCN Sequence Number Description | fluticasone/umeclidin/vilanter BLST W/DEV 200-62.5 INHALATION |
| HIC3 | B64 |
| HIC3 Description | BETA-ADRENERGIC-ANTICHOLINERGIC-GLUCOCORT, INHALED |
| GCN | 48708 |
| HICL Sequence Number | 044508 |
| HICL Sequence Number Description | FLUTICASONE FUROATE/UMECLIDINIUM BROMIDE/VILANTEROL TRIFENAT |
| Brand/Generic | Brand |
| Proprietary Name | Trelegy Ellipta |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | fluticasone furoate, umeclidinium bromide and vilanterol trifenatate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | POWDER |
| Route | RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 200; 62.5; 25 |
| Active Ingredient Units | ug/1; ug/1; ug/1 |
| Substance Name | FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE |
| Labeler Name | GlaxoSmithKline LLC |
| Pharmaceutical Class | Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA209482 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00173-0893-61 (00173089361)
| NDC Package Code | 0173-0893-61 |
|---|---|
| Billing NDC | 00173089361 |
| Package | 1 TRAY in 1 CARTON (0173-0893-61) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER |
| Marketing Start Date | 2020-09-09 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |