NDC codes

FDA NDC Directory
Product NDC (as listed)0173-0887Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00173-0887Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0173-0887-1000173088710001730887101 TRAY in 1 CARTON (0173-0887-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALERMarketed from Sep 18, 2017
0173-0887-1400173088714001730887141 TRAY in 1 CARTON (0173-0887-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALERMarketed from Sep 18, 2017
0173-0887-6100173088761001730887611 TRAY in 1 CARTON (0173-0887-61) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALERMarketed from Sep 18, 2017 · 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 — 100 ug/1Umeclidinium bromide — 62.5 ug/1Vilanterol trifenatate — 25 ug/1
Dosage form
Powder
Route
Respiratory (Inhalation)
Labeler
GlaxoSmithKline LLCNDC labeler code 0173
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 0173-0887_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 7AN603V4JV, JS86977WNV, 40AHO2C6DG
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

N400173088710 followed by a unit qualifier and the quantity

Package 00173-0887-10. 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.

Full label on DailyMed (opens in a new tab)

About NDC 0173-0887

What is NDC 0173-0887?
0173-0887 is the product NDC for Trelegy Ellipta, Fluticasone furoate 100 ug/1 + 2 more ingredients powder, listed with the FDA by GlaxoSmithKline LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Trelegy Ellipta (Fluticasone furoate, umeclidinium bromide and vilanterol trifenatate).
What is the active ingredient?
Fluticasone furoate, Umeclidinium bromide, Vilanterol trifenatate.
Who is the labeler?
GlaxoSmithKline LLC, NDC labeler code 0173. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Trelegy Ellipta?
1 other product NDC are listed under this name. See all Trelegy Ellipta NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Trelegy Ellipta NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Trelegy Elliptafluticasone furoate, umeclidinium bromide and vilanterol trifenatateFluticasone furoate 200 ug/1 + 2 more ingredientsPowderRespiratory (Inhalation)GlaxoSmithKline LLC0173-089300173-0893-1000173-0893-1400173-0893-61

Other NDCs under NDA 209482

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 209482
ProductStrengthForm · routeLabelerProduct NDC
Trelegy Elliptafluticasone furoate, umeclidinium bromide and vilanterol trifenatateFluticasone furoate 200 ug/1 + 2 more ingredientsPowderRespiratory (Inhalation)GlaxoSmithKline LLC0173-0893

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