What is NDC 0173-0869?

0173-0869 is the product NDC for Anoro Ellipta, Umeclidinium bromide 62.5 ug/1; Vilanterol trifenatate 25 ug/1 powder, listed with the FDA by GlaxoSmithKline LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Anoro Ellipta (Umeclidinium bromide and vilanterol trifenatate).

What is the active ingredient?

Umeclidinium bromide, Vilanterol trifenatate.

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 Anoro Ellipta?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Anoro Ellipta NDC 0173-0869 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0173-0869Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00173-0869Add 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
0173-0869-06	0017308690600173086906	1 TRAY in 1 CARTON (0173-0869-06) / 1 INHALER in 1 TRAY / 7 POWDER in 1 INHALERMarketed from Jan 31, 2014
0173-0869-10	0017308691000173086910	1 TRAY in 1 CARTON (0173-0869-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALERMarketed from Jan 31, 2014

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): Anoro Ellipta
Generic name (nonproprietary): umeclidinium bromide and vilanterol trifenatate
Active ingredients: Umeclidinium 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 203975
Marketing start: Jan 31, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta2-Agonists (Mechanism)Cholinergic Antagonists (Mechanism)
Identifiers: Product ID 0173-0869_90be6e26-9d2d-4b9d-8378-5e38c3076720SPL ID 90be6e26-9d2d-4b9d-8378-5e38c3076720SPL set ID 2dbd0671-c565-40c5-bf0f-e324db26799cRxCUI 1487519, 1487524, 1487527, 1487528UNII 7AN603V4JV, 40AHO2C6DG
Pharmacologic class: Anticholinergic; 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

N400173086906 followed by a unit qualifier and the quantity

Package 00173-0869-06. 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 Jun 2, 2023.

Indications (excerpt from the label)

ANORO ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use ANORO ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma. The safety and effectiveness of ANORO ELLIPTA in asthma have not been established. ANORO ELLIPTA is a combination of 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 ) Limitations of Use: Not indicated for relief of acute bronchospasm or for the treatment of asthma. ( 1 , 5.2 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0173-0869

What is NDC 0173-0869?: 0173-0869 is the product NDC for Anoro Ellipta, Umeclidinium bromide 62.5 ug/1; Vilanterol trifenatate 25 ug/1 powder, listed with the FDA by GlaxoSmithKline LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Anoro Ellipta (Umeclidinium bromide and vilanterol trifenatate).
What is the active ingredient?: 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 Anoro Ellipta?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 203975

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

FDA NDC Directory listings under NDA 203975
Product	Strength	Form · route	Labeler	Product NDC
Umeclidinium and Vilanterol Elliptaumeclidinium bromide and vilanterol trifenatate	Umeclidinium bromide 62.5 ug/1; Vilanterol trifenatate 25 ug/1	PowderRespiratory (Inhalation)	Prasco Laboratories	66993-134