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NDC 66993-0087-96 Fluticasone Propionate and Salmeterol HFA 115; 21 ug/1; ug/1 Details
Fluticasone Propionate and Salmeterol HFA 115; 21 ug/1; ug/1
Fluticasone Propionate and Salmeterol HFA is a RESPIRATORY (INHALATION) AEROSOL, METERED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Prasco Laboratories. The primary component is FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE.
MedlinePlus Drug Summary
The combination of fluticasone and salmeterol (Advair Diskus, Advair HFA, AirDuo Respiclick) is used to treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by asthma. The combination of fluticasone and salmeterol (Advair Diskus) is also used to prevent and treat wheezing, shortness of breath, coughing, and chest tightness caused by chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema). The combination of fluticasone and salmeterol (Advair Diskus) is used in adults and children 4 years of age and older. The combination of fluticasone and salmeterol (Advair HFA, AirDuo Respiclick) is used in children 12 years of age and older. Fluticasone is in a class of medications called steroids. It works by reducing swelling in the airways. Salmeterol is in a class of medications called long-acting beta-agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.
Related Packages: 66993-0087-96Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Fluticasone and Salmeterol Oral Inhalation
Product Information
| NDC | 66993-0087 |
|---|---|
| Product ID | 66993-087_1401102c-53a7-4303-9404-1e75f019f238 |
| Associated GPIs | |
| GCN Sequence Number | 061344 |
| GCN Sequence Number Description | fluticasone propion/salmeterol HFA AER AD 115-21MCG INHALATION |
| HIC3 | B63 |
| HIC3 Description | BETA-ADRENERGIC AND GLUCOCORTICOID COMBO, INHALED |
| GCN | 97136 |
| HICL Sequence Number | 019963 |
| HICL Sequence Number Description | FLUTICASONE PROPIONATE/SALMETEROL XINAFOATE |
| Brand/Generic | Generic |
| Proprietary Name | Fluticasone Propionate and Salmeterol HFA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | fluticasone propionate and salmeterol xinafoate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | AEROSOL, METERED |
| Route | RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 115; 21 |
| Active Ingredient Units | ug/1; ug/1 |
| Substance Name | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
| Labeler Name | Prasco Laboratories |
| Pharmaceutical Class | Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA AUTHORIZED GENERIC |
| Application Number | NDA021254 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 66993-0087-96 (66993008796)
| NDC Package Code | 66993-087-96 |
|---|---|
| Billing NDC | 66993008796 |
| Package | 1 INHALER in 1 CARTON (66993-087-96) / 120 AEROSOL, METERED in 1 INHALER |
| Marketing Start Date | 2023-03-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 21.1518 |
| Pricing Unit | GM |
| Effective Date | 2024-02-21 |
| NDC Description | FLUTICASONE-SALMETEROL 115-21 |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5, 6 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |