What this pack is
Trelegy Ellipta is the brand name in this record; fluticasone furoate, umeclidinium and vilanterol is the generic name. Read both together with the dosage form (inhaled product).
PACK CHECK · MARKET FIRST
Trelegy ElliptaGeneric namefluticasone furoate, umeclidinium and vilanterol
How this medicine works
The current label describes TRELEGY ELLIPTA as a fixed combination of the inhaled corticosteroid fluticasone furoate, the anticholinergic umeclidinium and the long-acting beta2-adrenergic agonist vilanterol. Mechanism helps explain why complete-list and device review matters; it does not predict individual lung function, acute symptoms, benefit, inhalation use or whether a switch is suitable.
Read source: United States ↗reviewed 2026-08-20More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- International brand name
- Trelegy Ellipta
- Generic name
- fluticasone furoate, umeclidinium and vilanterol
- Dosage-form class
- Three-ingredient dry-powder inhaler: 100 mcg/62.5 mcg/25 mcg or 200 mcg/62.5 mcg/25 mcg per inhalation (as listed in the current U.S. label)
- Route
- Oral inhalation
- Package-image status
- A source-linked public label image is available below
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
A mcg-per-inhalation value identifies the labelled contents of this exact inhaler. It does not calculate an individual's inhalation count, timing, acute-symptom action, combination or switch.
2 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · DailyMed SPL v14 published 2025-11-19
100/62.5/25 mcg per labelled inhalation; one ELLIPTA inhaler (30 labelled inhalations; 60 blisters)
- Product code
- NDC 0173-0887-10
- Form and route
- three-ingredient dry-powder inhaler · oral inhalation
- Container
- ELLIPTA dry-powder inhaler
- Units in each inner container
- 30 labelled inhalationsPackage identity only; not an individual amount to take
- Delivery device
- ELLIPTA inhaler
- fluticasone furoate
- 100 mcglabelled ingredient amount per inhalation; not an individual's use instruction
- umeclidinium
- 62.5 mcglabelled ingredient amount per inhalation; not an individual's use instruction
- vilanterol
- 25 mcglabelled ingredient amount per inhalation; not an individual's use instruction
- Package
- 1 inhaler per carton (30 labelled inhalations; 60 blisters)
United States label · DailyMed SPL v14 published 2025-11-19
200/62.5/25 mcg per labelled inhalation; one ELLIPTA inhaler (30 labelled inhalations; 60 blisters)
- Product code
- NDC 0173-0893-10
- Form and route
- three-ingredient dry-powder inhaler · oral inhalation
- Container
- ELLIPTA dry-powder inhaler
- Units in each inner container
- 30 labelled inhalationsPackage identity only; not an individual amount to take
- Delivery device
- ELLIPTA inhaler
- fluticasone furoate
- 200 mcglabelled ingredient amount per inhalation; not an individual's use instruction
- umeclidinium
- 62.5 mcglabelled ingredient amount per inhalation; not an individual's use instruction
- vilanterol
- 25 mcglabelled ingredient amount per inhalation; not an individual's use instruction
- Package
- 1 inhaler per carton (30 labelled inhalations; 60 blisters)
PUBLIC LABEL IMAGE
Appearance and package-text clues
This dated or historical public-label image is for checking the brand, generic-name, strength and dosage-form clues only. It does not authenticate a product or establish originator status, a current label, current packaging, target-market approval or sale eligibility.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
TRELEGY ELLIPTA label reading: 100/62.5/25 identifies three ingredients and one device
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
This module uses the current U.S. public label to check TRELEGY ELLIPTA, all three ingredients, the complete three-number marking, dry-powder inhaler, NDC and label version. It does not decide individual inhalation use, device operation, co-use with another inhaler, adjustment or self-management of an acute symptom.
- 100/62.5/25 and 200/62.5/25 mcg are complete three-ingredient markings per inhalation, not a formula a webpage can split, add or convert into an individual's inhalation use. Also check the device, NDC, pack count, target market and label version together.
- TRELEGY ELLIPTA is not self-combinable, alternatable, substitutable or device-shareable with VENTOLIN HFA, ANORO ELLIPTA, INCRUSE ELLIPTA, BREO ELLIPTA or another inhaler merely because labels mention inhalation, ELLIPTA or one shared ingredient.
- The current label states it is not indicated for relief of acute bronchospasm. Sudden or worsening breathing difficulty, chest pain, cyanosis, trouble speaking, fainting or another acute concern needs the local urgent-care plan and clinician guidance, not self-added, make-up or changed inhaler use from this page.
- Device opening, storage, cleaning, inhalation technique and remaining-dose counting must return to the patient instructions for the actual product and demonstration by a pharmacist/prescribing team; this page only helps locate the exact label and cannot replace device teaching.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-20
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 1
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeDailyMed (NLM): current U.S. TRELEGY ELLIPTA fluticasone furoate/umeclidinium/vilanterol public label (GSK; SPL v14) ↗reviewed 2026-08-20
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about Trelegy Ellipta (fluticasone furoate, umeclidinium and vilanterol). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
Trelegy Ellipta is the brand in this record and fluticasone furoate, umeclidinium and vilanterol is the active-ingredient name. Check both with the dosage form (Three-ingredient dry-powder inhaler: 100 mcg/62.5 mcg/25 mcg or 200 mcg/62.5 mcg/25 mcg per inhalation (as listed in the current U.S. label)) and the market on the actual pack.
Read the labelled strength in context
mcg per actuation, dose count or a two-number strength describes the labelled inhaler and device identity. It is not an individual inhalation count or rescue plan.
Check the exact inhaler or device
For an inhaled product, verify the device, labelled strength and current instructions for that exact pack. Do not transfer, share or replace a device on the basis of a similar name.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
HOW IT WORKS · NOT A TREATMENT PLAN
How three inhaled ingredients appear together: ICS, anticholinergic and long-acting beta2-agonist pathways
- Three pathways do not mean another LABA-, anticholinergic- or inhaled-corticosteroid-containing product can be self-added. Any addition, stopping, alternation or substitution needs a pharmacist or clinician to review the complete list and exact devices item by item.
- ‘Maintenance’, ‘inhalation’, ‘bronchodilation’ or a shared device-family name cannot turn this product into a general acute-symptom answer or make one device's operation automatically apply to another.
- A mechanism explanation cannot manage eye pain/vision change, urinary difficulty, palpitations, allergy, infection signs or any severe respiratory symptom. With these concerns, use local medical support rather than self-adjusting from mechanism text.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
SOURCE-TRACEABLE ARCHIVE
Trelegy Elliptafluticasone furoate, umeclidinium and vilanterol
This page links to public primary-source material for Trelegy Ellipta. The archive is historical or documentary evidence only; it does not by itself establish originator status, product quality, current labelling, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
NDA 209482 original application approval
The FDA Drugs@FDA public record lists TRELEGY ELLIPTA original application (ORIG 1) as approved on 18 Sep 2017. This U.S. regulatory node does not establish approval, supply or individual suitability in another market.
FDA: TRELEGY ELLIPTA NDA 209482 original approval letter (2017-09-18) ↗Initial U.S. approval year listed in the current label
The current TRELEGY ELLIPTA label lists Initial U.S. Approval: 2017; it does not establish product status in another market.
DailyMed: current TRELEGY ELLIPTA public label, SPL v14 ↗Current SPL v14 published on DailyMed
DailyMed lists 19 Nov 2025 as the current v14 Published Date; it does not represent individual use, availability or supply status.
DailyMed: current TRELEGY ELLIPTA public label, SPL v14 ↗
MARKET SCOPE
Market-record boundary
United States
Current three-ingredient label and one exact carton panel linkedThe image corresponds only to 100/62.5/25 mcg, NDC 0173-0887-10 and 30 inhalations (60 blisters); it does not establish actual marketing, stock, individual device operation or another-strength status.
Mainland China, EU, Japan and other markets
Market record not establishedNo local trade name, approval, device, supply, originator relationship or interchangeability is inferred from the U.S. label.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
Keep international and mainland China records separate
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
RECORD FAQ
Record questions
Can 100/62.5/25 mcg be read as just one of its three numbers?
No. It is the complete per-inhalation identity marking for this exact three-ingredient inhaler. The page does not turn it into individual inhalation use, device operation, adjustment or conversion to another inhaler.
Can TRELEGY ELLIPTA be self-switched with another ELLIPTA or rescue inhaler?
No. Similar device names, shared ingredients or respiratory use do not establish self-interchangeability. The label also states it is not for relief of acute bronchospasm; take the actual devices and complete medicine list to a pharmacist or prescribing team.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.