AirDuo RespiClick
- Product NDC
- 59310-805
- 11-digit product format
- 593100805
- Labeler code
- 59310
- Product ID
- 59310-805_b597bc2d-bf1e-4f9b-826a-b3e39ed56545
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluticasone Propionate and Salmeterol
- Dosage form
- POWDER, METERED
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Teva Respiratory, LLC
- Application
- NDA208799
- Marketing category
- NDA
- Marketing start
- 2017-04-12
- Substance
- FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
- Active strength
- 55; 14 ug/1; ug/1
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AirDuo RespiClick
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUTICASONE PROPIONATE | 55 ug/1 |
| SALMETEROL XINAFOATE | 14 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6EW8Q962A5, O2GMZ0LF5W |
| Rxcui | 1918194, 1918199, 1918203, 1918205, 1918209, 1918211 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59310-805-06 | AirDuo RespiClick | 1 in 1 POUCH | POWDER, METERED | 1 | | 16 |
| 59310-805-06 | AirDuo RespiClick | 1 in 1 CARTON | POWDER, METERED | 1 | | 16 |
| 59310-805-08 | AirDuo RespiClick | 1 in 1 POUCH | POWDER, METERED | 1 | | 16 |
| 59310-805-08 | AirDuo RespiClick | 1 in 1 CARTON | POWDER, METERED | 1 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59310-805 | AIRDUO RESPICLICK (FLUTICASONE PROPIONATE AND SALMETEROL) POWDER, METERED [TEVA RESPIRATORY, LLC] | 16 | Current NDC, Legacy NDC, 4 package rows | 20240207_9c122b91-a11f-49ca-80bb-3eec5112db87.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1918199 | AirDuo RespiClick 113/14 MCG/INHAL Dry Powder Inhaler, 60 Actuations | PSN | 9c122b91-a11f-49ca-80bb-3eec5112db87 | 16 |
| 1918205 | AirDuo RespiClick 232/14 MCG/INHAL Dry Powder Inhaler, 60 Actuations | PSN | 9c122b91-a11f-49ca-80bb-3eec5112db87 | 16 |
| 1918211 | AirDuo RespiClick 55/14 MCG/INHAL Dry Powder Inhaler, 60 Actuations | PSN | 9c122b91-a11f-49ca-80bb-3eec5112db87 | 16 |
| 1918194 | fluticasone propionate/salmeterol 113/14 MCG/INHAL Dry Powder Inhaler, 60 Actuations | PSN | 9c122b91-a11f-49ca-80bb-3eec5112db87 | 16 |
| 1918203 | fluticasone propionate/salmeterol 232/14 MCG/INHAL Dry Powder Inhaler, 60 Actuations | PSN | 9c122b91-a11f-49ca-80bb-3eec5112db87 | 16 |
| 1918209 | fluticasone propionate/salmeterol 55/14 MCG/INHAL Dry Powder Inhaler, 60 Actuations | PSN | 9c122b91-a11f-49ca-80bb-3eec5112db87 | 16 |
| 1918211 | 60 ACTUAT fluticasone propionate 0.055 MG/ACTUAT / salmeterol 0.014 MG/ACTUAT Dry Powder Inhaler [AirDuo] | SBD | 9c122b91-a11f-49ca-80bb-3eec5112db87 | 16 |
| 1918199 | 60 ACTUAT fluticasone propionate 0.113 MG/ACTUAT / salmeterol 0.014 MG/ACTUAT Dry Powder Inhaler [AirDuo] | SBD | 9c122b91-a11f-49ca-80bb-3eec5112db87 | 16 |
| 1918205 | 60 ACTUAT fluticasone propionate 0.232 MG/ACTUAT / salmeterol 0.014 MG/ACTUAT Dry Powder Inhaler [AirDuo] | SBD | 9c122b91-a11f-49ca-80bb-3eec5112db87 | 16 |
| 1918209 | 60 ACTUAT fluticasone propionate 0.055 MG/ACTUAT / salmeterol 0.014 MG/ACTUAT Dry Powder Inhaler | SCD | 9c122b91-a11f-49ca-80bb-3eec5112db87 | 16 |
| 1918194 | 60 ACTUAT fluticasone propionate 0.113 MG/ACTUAT / salmeterol 0.014 MG/ACTUAT Dry Powder Inhaler | SCD | 9c122b91-a11f-49ca-80bb-3eec5112db87 | 16 |
| 1918203 | 60 ACTUAT fluticasone propionate 0.232 MG/ACTUAT / salmeterol 0.014 MG/ACTUAT Dry Powder Inhaler | SCD | 9c122b91-a11f-49ca-80bb-3eec5112db87 | 16 |
| 1918199 | AirDuo 113/14 (fluticasone propionate 113 MCG / salmeterol 14 MCG (equivalent to salmeterol xinafoate 20.3 MCG)) per ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | 9c122b91-a11f-49ca-80bb-3eec5112db87 | 16 |
| 1918205 | AirDuo 232/14 (fluticasone propionate 232 MCG / salmeterol 14 MCG (equivalent to salmeterol xinafoate 20.3 MCG)) per ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | 9c122b91-a11f-49ca-80bb-3eec5112db87 | 16 |
| 1918211 | AirDuo 55/14 (fluticasone propionate 55 MCG / salmeterol 14 MCG (equivalent to salmeterol xinafoate 20.3 MCG)) per ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | 9c122b91-a11f-49ca-80bb-3eec5112db87 | 16 |
| 1918199 | AirDuo RespiClick 113/14 Dry Powder Inhaler, 60 ACTUAT | SY | 9c122b91-a11f-49ca-80bb-3eec5112db87 | 16 |
| 1918205 | AirDuo RespiClick 232/14 Dry Powder Inhaler, 60 ACTUAT | SY | 9c122b91-a11f-49ca-80bb-3eec5112db87 | 16 |
| 1918211 | AirDuo RespiClick 55/14 Dry Powder Inhaler, 60 ACTUAT | SY | 9c122b91-a11f-49ca-80bb-3eec5112db87 | 16 |
| 1918194 | fluticasone propionate 113 MCG/ACTUAT / salmeterol xinafoate 14 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUATS | SY | 9c122b91-a11f-49ca-80bb-3eec5112db87 | 16 |
| 1918203 | fluticasone propionate 232 MCG/ACTUAT / salmeterol xinafoate 14 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUATS | SY | 9c122b91-a11f-49ca-80bb-3eec5112db87 | 16 |
| 1918209 | fluticasone propionate 55 MCG/ACTUAT / salmeterol xinafoate 14 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUATS | SY | 9c122b91-a11f-49ca-80bb-3eec5112db87 | 16 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59310-805-06 | 59310080506 | 1 POUCH in 1 CARTON (59310-805-06) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER | 1 pouch | 2017-04-24 | 0000-00-00 | No | No | Current |
| 59310-805-08 | 59310080508 | 1 POUCH in 1 CARTON (59310-805-08) > 1 INHALER in 1 POUCH > 60 POWDER, METERED in 1 INHALER | 1 pouch | 2017-04-12 | 0000-00-00 | No | No | Current |