Prescription drug · NDA
Trelegy Ellipta NDC 0173-0893
fluticasone furoate, umeclidinium bromide and vilanterol trifenatate · Fluticasone furoate 200 ug/1 + 2 more ingredients · Powder · Respiratory (Inhalation) · GlaxoSmithKline LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0173-0893-10 | 00173089310 | 1 TRAY in 1 CARTON (0173-0893-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALERMarketed from Sep 9, 2020 | |
| 0173-0893-14 | 00173089314 | 1 TRAY in 1 CARTON (0173-0893-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALERMarketed from Sep 9, 2020 | |
| 0173-0893-61 | 00173089361 | 1 TRAY in 1 CARTON (0173-0893-61) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALERMarketed from Sep 9, 2020 · Sample package |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Trelegy Ellipta
- Generic name (nonproprietary)
- fluticasone furoate, umeclidinium bromide and vilanterol trifenatate
- Active ingredients
- Fluticasone furoate — 200 ug/1Umeclidinium bromide — 62.5 ug/1Vilanterol trifenatate — 25 ug/1
- Dosage form
- Powder
- Route
- Respiratory (Inhalation)
- Labeler
- GlaxoSmithKline LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209482
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)Cholinergic Antagonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0173-0893_dd604365-bcae-4ef7-a69e-71dcbebfa98bSPL ID dd604365-bcae-4ef7-a69e-71dcbebfa98bSPL set ID b5a81d5a-4648-4c7a-951d-33c014a63c7eRxCUI 1945039, 1945044, 1945047, 1945048, 2395769, 2395771, 2395774, 2395775UNII 40AHO2C6DG, 7AN603V4JV, JS86977WNV
- Pharmacologic class
- Anticholinergic; Corticosteroid; beta2-Adrenergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N400173089310followed by a unit qualifier and the quantityPackage 00173-0893-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta 2 -adrenergic agonist (LABA), indicated for: • the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ( 1.1 ) • the maintenance treatment of asthma in patients aged 18 years and older. ( 1.2 ) Limitations of Use: Not indicated for relief of acute bronchospasm. ( 1.3 , 5.2 ) 1.1 Maintenance Treatment of Chronic Obstructive Pulmonary Disease TRELEGY ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). 1.2 Maintenance Treatment of Asthma TRELEGY…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 209482
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Trelegy Elliptafluticasone furoate, umeclidinium bromide and vilanterol trifenatate | Fluticasone furoate 100 ug/1 + 2 more ingredients | PowderRespiratory (Inhalation) | GlaxoSmithKline LLC | 0173-0887 |