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NDC 63654-0380-01 Fluticasone Propionate 50 ug/1 Details
Fluticasone Propionate 50 ug/1
Fluticasone Propionate is a NASAL SPRAY, METERED in the HUMAN OTC DRUG category. It is labeled and distributed by Selder, S.A. de C.V.. The primary component is FLUTICASONE PROPIONATE.
MedlinePlus Drug Summary
Nonprescription fluticasone nasal spray (Flonase Allergy) is used to relieve symptoms of rhinitis such as sneezing and a runny, stuffy, or itchy nose and itchy, watery eyes caused by hay fever or other allergies (caused by an allergy to pollen, mold, dust, or pets). Prescription fluticasone is also used to relieve symptoms of nonallergic rhinitis such as sneezing and runny or stuffy nose which are not caused by allergies. Prescription fluticasone nasal spray (Xhance) is used to treat nasal polyps (swelling of the lining of the nose). Fluticasone nasal spray should not be used to treat symptoms (e.g., sneezing, stuffy, runny, itchy nose) caused by the common cold. Fluticasone is in a class of medications called corticosteroids. It works by blocking the release of certain natural substances that cause allergy symptoms.
Related Packages: 63654-0380-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fluticasone Nasal Spray
Product Information
| NDC | 63654-0380 |
|---|---|
| Product ID | 63654-380_9519d5f7-acd5-4700-9738-08cef7e54083 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Fluticasone Propionate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Fluticasone Propionate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SPRAY, METERED |
| Route | NASAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | ug/1 |
| Substance Name | FLUTICASONE PROPIONATE |
| Labeler Name | Selder, S.A. de C.V. |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA208150 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63654-0380-01 (63654038001)
| NDC Package Code | 63654-380-01 |
|---|---|
| Billing NDC | 63654038001 |
| Package | 1 BOTTLE, SPRAY in 1 CARTON (63654-380-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY |
| Marketing Start Date | 2017-05-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |