Prescription drug · NDA AUTHORIZED GENERIC
Fluticasone Furoate and Vilanterol NDC 66993-136
Fluticasone furoate 200 ug/1; Vilanterol trifenatate 25 ug/1 · Powder · Respiratory (Inhalation) · Prasco Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66993-136-97 | 66993013697 | 1 TRAY in 1 CARTON (66993-136-97) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALERMarketed from May 23, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Fluticasone Furoate and Vilanterol
- Generic name (nonproprietary)
- fluticasone furoate and vilanterol
- Active ingredients
- Fluticasone furoate — 200 ug/1Vilanterol trifenatate — 25 ug/1
- Dosage form
- Powder
- Route
- Respiratory (Inhalation)
- Labeler
- Prasco Laboratories
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 204275
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 66993-136_cdb395b6-2cfd-43d5-affa-68ce02b77312SPL ID cdb395b6-2cfd-43d5-affa-68ce02b77312SPL set ID 3a761487-c300-451a-8537-3196c00c11b5RxCUI 1424889, 1648788UNII 40AHO2C6DG, JS86977WNV
- 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
N466993013697followed by a unit qualifier and the quantityPackage 66993-0136-97. 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)
Fluticasone Furoate/Vilanterol 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 Fluticasone Furoate/Vilanterol ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). 1.2 Maintenance Treatment of Asthma Fluticasone…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 204275
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 |
|---|---|---|---|---|
| Breo Elliptafluticasone furoate and vilanterol trifenatate | Fluticasone furoate 50 ug/1; Vilanterol trifenatate 25 ug/1 | PowderRespiratory (Inhalation) | GlaxoSmithKline LLC | 0173-0916 |
| Breo Elliptafluticasone furoate and vilanterol trifenatate | Fluticasone furoate 100 ug/1; Vilanterol trifenatate 25 ug/1 | PowderRespiratory (Inhalation) | GlaxoSmithKline LLC | 0173-0859 |
| 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 |