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NDC 00054-0328-56 fluticasone propionate and salmeterol 500; 50 ug/1; ug/1 Details
fluticasone propionate and salmeterol 500; 50 ug/1; ug/1
fluticasone propionate and salmeterol is a RESPIRATORY (INHALATION) POWDER in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. 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: 00054-0328-56Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Fluticasone and Salmeterol Oral Inhalation
Product Information
| NDC | 00054-0328 |
|---|---|
| Product ID | 0054-0328_2af0cc77-a2bd-478e-b2e8-e9b125f564de |
| Associated GPIs | |
| GCN Sequence Number | 043368 |
| GCN Sequence Number Description | fluticasone propion/salmeterol BLST W/DEV 500-50 MCG INHALATION |
| HIC3 | B63 |
| HIC3 Description | BETA-ADRENERGIC AND GLUCOCORTICOID COMBO, INHALED |
| GCN | 50604 |
| 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 |
| Route | RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 500; 50 |
| Active Ingredient Units | ug/1; ug/1 |
| Substance Name | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
| Labeler Name | Hikma Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA203433 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00054-0328-56 (00054032856)
| NDC Package Code | 0054-0328-56 |
|---|---|
| Billing NDC | 00054032856 |
| Package | 1 POUCH in 1 CARTON (0054-0328-56) / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALER |
| Marketing Start Date | 2023-12-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |