Breo Ellipta NDC 0173-0859

NDC codes

FDA NDC Directory

Product NDC (as listed)0173-0859Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00173-0859Add 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 NDC	11-digit (billing)	Package	Copy
0173-0859-10	00173085910	1 TRAY in 1 CARTON (0173-0859-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALERMarketed from Aug 26, 2013
0173-0859-14	00173085914	1 TRAY in 1 CARTON (0173-0859-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALERMarketed from Aug 26, 2013

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): Breo Ellipta
Generic name (nonproprietary): fluticasone furoate and vilanterol trifenatate
Active ingredients: Fluticasone furoate — 100 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 204275
Marketing start: Aug 26, 2013
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta2-Agonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0173-0859_10ccfa0a-0453-41bd-b092-d62863a82c26SPL ID 10ccfa0a-0453-41bd-b092-d62863a82c26SPL set ID 96428df1-ea05-431a-98d3-1ec2c4b63878RxCUI 1424889, 1424899, 1539891, 1539893, 1648783, 1648785, 1648788, 1648789, 2637473, 2637476UNII JS86977WNV, 40AHO2C6DG
Pharmacologic class: 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

N400173085910 followed by a unit qualifier and the quantity

Package 00173-0859-10. 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 Nov 7, 2024.

Indications (excerpt from the label)

BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, 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 5 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 BREO ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). 1.2 Maintenance Treatment of Asthma BREO ELLIPTA is indicated for the maintenance treatment of asth…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 204275

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

FDA NDC Directory listings under NDA 204275
Product	Strength	Form · route	Labeler	Product NDC
Breo Elliptafluticasone furoate and vilanterol trifenatate	Fluticasone furoate 50 ug/1; Vilanterol trifenatate 25 ug/1	PowderRespiratory (Inhalation)	GlaxoSmithKline LLC	0173-0916
Fluticasone Furoate and Vilanterol	Fluticasone furoate 200 ug/1; Vilanterol trifenatate 25 ug/1	PowderRespiratory (Inhalation)	Prasco Laboratories	66993-136
Fluticasone Furoate and Vilanterol	Fluticasone furoate 100 ug/1; Vilanterol trifenatate 25 ug/1	PowderRespiratory (Inhalation)	Prasco Laboratories	66993-135
Breo Elliptafluticasone furoate and vilanterol trifenatate	Fluticasone furoate 200 ug/1; Vilanterol trifenatate 25 ug/1	PowderRespiratory (Inhalation)	GlaxoSmithKline LLC	0173-0882