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NDC 63629-8809-01 Fluticasone Propionate and Salmeterol 113; 14 ug/1; ug/1 Details
Fluticasone Propionate and Salmeterol 113; 14 ug/1; ug/1
Fluticasone Propionate and Salmeterol is a RESPIRATORY (INHALATION) POWDER, METERED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. 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: 63629-8809-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fluticasone and Salmeterol Oral Inhalation
Product Information
| NDC | 63629-8809 |
|---|---|
| Product ID | 63629-8809_3e4fb614-2598-4616-b4e9-b53079df47e4 |
| Associated GPIs | 44209902708015 |
| GCN Sequence Number | 077073 |
| GCN Sequence Number Description | fluticasone propion/salmeterol AER POW BA 113-14 MCG INHALATION |
| HIC3 | B63 |
| HIC3 Description | BETA-ADRENERGIC AND GLUCOCORTICOID COMBO, INHALED |
| GCN | 42957 |
| HICL Sequence Number | 019963 |
| HICL Sequence Number Description | FLUTICASONE PROPIONATE/SALMETEROL XINAFOATE |
| Brand/Generic | Generic |
| Proprietary Name | Fluticasone Propionate and Salmeterol |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Fluticasone Propionate and Salmeterol |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | POWDER, METERED |
| Route | RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 113; 14 |
| Active Ingredient Units | ug/1; ug/1 |
| Substance Name | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
| Labeler Name | Bryant Ranch Prepack |
| 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 | NDA208799 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63629-8809-01 (63629880901)
| NDC Package Code | 63629-8809-1 |
|---|---|
| Billing NDC | 63629880901 |
| Package | 1 POUCH in 1 CARTON (63629-8809-1) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER |
| Marketing Start Date | 2021-09-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |