Prescription drug · NDA
AirDuo RespiClick (Fluticasone propionate and salmeterol) NDC 59310-805
Fluticasone propionate 55 ug/1; Salmeterol xinafoate 14 ug/1 · Powder, Metered · Respiratory (Inhalation) · Teva Respiratory, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59310-805-06 | 5931008050659310080506 | 1 POUCH in 1 CARTON (59310-805-06) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALERMarketed from Apr 24, 2017 |
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)
- AirDuo RespiClick
- Generic name (nonproprietary)
- fluticasone propionate and salmeterol
- Active ingredients
- Fluticasone propionate — 55 ug/1Salmeterol xinafoate — 14 ug/1
- Dosage form
- Powder, Metered
- Route
- Respiratory (Inhalation)
- Labeler
- Teva Respiratory, LLCNDC labeler code 59310
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208799
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 59310-805_e8df87d3-fa81-4e19-9cd8-429a5f900395SPL ID e8df87d3-fa81-4e19-9cd8-429a5f900395
- 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
N459310080506followed by a unit qualifier and the quantityPackage 59310-0805-06. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 59310-805
- What is NDC 59310-805?
- 59310-805 is the product NDC for AirDuo RespiClick, Fluticasone propionate 55 ug/1; Salmeterol xinafoate 14 ug/1 powder, metered, listed with the FDA by Teva Respiratory, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- AirDuo RespiClick (Fluticasone Propionate and Salmeterol).
- What is the active ingredient?
- Fluticasone propionate, Salmeterol xinafoate.
- Who is the labeler?
- Teva Respiratory, LLC, NDC labeler code 59310. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for AirDuo RespiClick?
- 2 other product NDCs are listed under this name. See all AirDuo RespiClick NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other AirDuo RespiClick products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| AirDuo RespiClickfluticasone propionate and salmeterol | Fluticasone propionate 113 ug/1; Salmeterol xinafoate 14 ug/1 | Powder, MeteredRespiratory (Inhalation) | Teva Respiratory, LLC | 59310-812 | 59310-0812-06 |
| AirDuo RespiClickfluticasone propionate and salmeterol | Fluticasone propionate 232 ug/1; Salmeterol xinafoate 14 ug/1 | Powder, MeteredRespiratory (Inhalation) | Teva Respiratory, LLC | 59310-822 | 59310-0822-06 |
Other NDCs under NDA 208799
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 Propionate and Salmeterol | Fluticasone propionate 113 ug/1; Salmeterol xinafoate 14 ug/1 | Powder, MeteredRespiratory (Inhalation) | Teva Pharmaceuticals USA, Inc. | 0093-3608 |
| Fluticasone Propionate and Salmeterol | Fluticasone propionate 55 ug/1; Salmeterol xinafoate 14 ug/1 | Powder, MeteredRespiratory (Inhalation) | Teva Pharmaceuticals USA, Inc. | 0093-3607 |
| Fluticasone Propionate and Salmeterol | Fluticasone propionate 232 ug/1; Salmeterol xinafoate 14 ug/1 | Powder, MeteredRespiratory (Inhalation) | Teva Pharmaceuticals USA, Inc. | 0093-3609 |
| AirDuo RespiClickfluticasone propionate and salmeterol | Fluticasone propionate 232 ug/1; Salmeterol xinafoate 14 ug/1 | Powder, MeteredRespiratory (Inhalation) | Teva Respiratory, LLC | 59310-822 |
| AirDuo RespiClickfluticasone propionate and salmeterol | Fluticasone propionate 113 ug/1; Salmeterol xinafoate 14 ug/1 | Powder, MeteredRespiratory (Inhalation) | Teva Respiratory, LLC | 59310-812 |
| Fluticasone Propionate and Salmeterol | Fluticasone propionate 55 ug/1; Salmeterol xinafoate 14 ug/1 | Powder, MeteredRespiratory (Inhalation) | Bryant Ranch Prepack | 63629-8811 |
| Fluticasone Propionate and Salmeterol | Fluticasone propionate 113 ug/1; Salmeterol xinafoate 14 ug/1 | Powder, MeteredRespiratory (Inhalation) | Bryant Ranch Prepack | 63629-8809 |
| Fluticasone Propionate and Salmeterol | Fluticasone propionate 232 ug/1; Salmeterol xinafoate 14 ug/1 | Powder, MeteredRespiratory (Inhalation) | Bryant Ranch Prepack | 63629-8810 |
| Fluticasone Propionate and Salmeterol | Fluticasone propionate 113 ug/1; Salmeterol xinafoate 14 ug/1 | Powder, MeteredRespiratory (Inhalation) | A-S Medication Solutions | 50090-3271 |
| Fluticasone Propionate and Salmeterol | Fluticasone propionate 55 ug/1; Salmeterol xinafoate 14 ug/1 | Powder, MeteredRespiratory (Inhalation) | A-S Medication Solutions | 50090-3272 |
| Fluticasone Propionate and Salmeterol | Fluticasone propionate 232 ug/1; Salmeterol xinafoate 14 ug/1 | Powder, MeteredRespiratory (Inhalation) | A-S Medication Solutions | 50090-3387 |