Prescription drug · NDA
Arnuity Ellipta (fluticasone furoate) NDC 0173-0874
Fluticasone furoate 100 ug/1 · Powder · Respiratory (Inhalation) · GlaxoSmithKline LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0173-0874-10 | 00173087410 | 1 INHALER in 1 CARTON (0173-0874-10) / 30 POWDER in 1 INHALERMarketed from Aug 20, 2014 | |
| 0173-0874-14 | 00173087414 | 1 INHALER in 1 CARTON (0173-0874-14) / 14 POWDER in 1 INHALERMarketed from Aug 20, 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)
- Arnuity Ellipta
- Generic name (nonproprietary)
- fluticasone furoate
- Active ingredients
- Fluticasone furoate — 100 ug/1
- Dosage form
- Powder
- Route
- Respiratory (Inhalation)
- Labeler
- GlaxoSmithKline LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205625
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0173-0874_aab25efb-3b3e-462a-bdae-5dfe807b11acSPL ID aab25efb-3b3e-462a-bdae-5dfe807b11acSPL set ID 50f193ee-1691-486d-9370-a664df63695cRxCUI 1547658, 1547660, 1547663, 1547664, 1547666, 1547668, 1547671, 1547672, 2045377, 2045382UNII JS86977WNV
- Pharmacologic class
- Corticosteroid
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
N400173087410followed by a unit qualifier and the quantityPackage 00173-0874-10. 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)
ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm. ARNUITY ELLIPTA is an inhaled corticosteroid indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. ( 1 ) Limitations of Use: Not indicated for relief of acute bronchospasm. ( 1 , 5.2 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 205625
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 |
|---|---|---|---|---|
| Fluticasone Furoate Elliptafluticasone furoate | Fluticasone furoate 50 ug/1 | PowderRespiratory (Inhalation) | Prasco Laboratories | 66993-166 |
| Fluticasone Furoate Elliptafluticasone furoate | Fluticasone furoate 100 ug/1 | PowderRespiratory (Inhalation) | Prasco Laboratories | 66993-167 |
| Fluticasone Furoate Elliptafluticasone furoate | Fluticasone furoate 200 ug/1 | PowderRespiratory (Inhalation) | Prasco Laboratories | 66993-168 |
| Arnuity Elliptafluticasone furoate | Fluticasone furoate 200 ug/1 | PowderRespiratory (Inhalation) | GlaxoSmithKline LLC | 0173-0876 |
| Arnuity Elliptafluticasone furoate | Fluticasone furoate 50 ug/1 | PowderRespiratory (Inhalation) | GlaxoSmithKline LLC | 0173-0888 |