Fluticasone Propionate and Salmeterol HFA
- Product NDC
- 66993-087
- 11-digit product format
- 669930087
- Labeler code
- 66993
- Product ID
- 66993-087_7a85b8b8-7336-4563-9cf7-a03693e08f70
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluticasone propionate and salmeterol xinafoate
- Dosage form
- AEROSOL, METERED
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Prasco Laboratories
- Application
- NDA021254
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2023-03-01
- Substance
- FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
- Active strength
- 115; 21 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluticasone Propionate and Salmeterol HFA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUTICASONE PROPIONATE | 115 ug/1 |
| SALMETEROL XINAFOATE | 21 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O2GMZ0LF5W, 6EW8Q962A5 |
| Rxcui | 896236, 896244, 896272 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66993-087-96 | Fluticasone Propionate and Salmeterol HFA | 1 in 1 CARTON | AEROSOL, METERED | 1 | | 5 |
| 66993-087-96 | Fluticasone Propionate and Salmeterol HFA | 120 in 1 INHALER | AEROSOL, METERED | 120 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66993-087 | FLUTICASONE PROPIONATE AND SALMETEROL HFA (FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE) AEROSOL, METERED [PRASCO LABORATORIES] | 4 | Current NDC, 2 package rows | 20250525_666c5b12-a4f7-4c53-8261-4742b5e5a6df.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 896244 | fluticasone propionate/salmeterol 115/21 MCG/INHAL Metered Dose Inhaler, 120 Actuations | PSN | 666c5b12-a4f7-4c53-8261-4742b5e5a6df | 5 |
| 896272 | fluticasone propionate/salmeterol 230/21 MCG/INHAL Metered Dose Inhaler, 120 Actuations | PSN | 666c5b12-a4f7-4c53-8261-4742b5e5a6df | 5 |
| 896236 | fluticasone propionate/salmeterol 45/21 MCG/INHAL Metered Dose Inhaler, 120 Actuations | PSN | 666c5b12-a4f7-4c53-8261-4742b5e5a6df | 5 |
| 896236 | 120 ACTUAT fluticasone propionate 0.045 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose Inhaler | SCD | 666c5b12-a4f7-4c53-8261-4742b5e5a6df | 5 |
| 896244 | 120 ACTUAT fluticasone propionate 0.115 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose Inhaler | SCD | 666c5b12-a4f7-4c53-8261-4742b5e5a6df | 5 |
| 896272 | 120 ACTUAT fluticasone propionate 0.23 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose Inhaler | SCD | 666c5b12-a4f7-4c53-8261-4742b5e5a6df | 5 |
| 896236 | fluticasone propionate 0.045 MG / salmeterol 0.021 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT | SY | 666c5b12-a4f7-4c53-8261-4742b5e5a6df | 5 |
| 896244 | fluticasone propionate 0.115 MG / salmeterol 0.021 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT | SY | 666c5b12-a4f7-4c53-8261-4742b5e5a6df | 5 |
| 896272 | fluticasone propionate 0.23 MG / salmeterol 0.021 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT | SY | 666c5b12-a4f7-4c53-8261-4742b5e5a6df | 5 |
| 896244 | fluticasone propionate 115 MCG / salmeterol 21 MCG (salmeterol xinafoate 30.45 MCG) per ACTUAT Metered Dose Inhaler, 120 ACTUAT | SY | 666c5b12-a4f7-4c53-8261-4742b5e5a6df | 5 |
| 896272 | fluticasone propionate 230 MCG / salmeterol 21 MCG (salmeterol xinafoate 30.45 MCG) per ACTUAT Metered Dose Inhaler, 120 ACTUAT | SY | 666c5b12-a4f7-4c53-8261-4742b5e5a6df | 5 |
| 896236 | fluticasone propionate 45 MCG / salmeterol 21 MCG (salmeterol xinafoate 30.45 MCG) per ACTUAT Metered Dose Inhaler, 120 ACTUAT | SY | 666c5b12-a4f7-4c53-8261-4742b5e5a6df | 5 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 66993-087-96 | 66993008796 | 1 INHALER in 1 CARTON (66993-087-96) / 120 AEROSOL, METERED in 1 INHALER | 1 inhaler | 2023-03-01 | No | No | Current |