Search by Drug Name or NDC
NDC 50383-0968-16 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 Akorn. 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: 50383-0968-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluticasone Nasal Spray
Product Information
| NDC | 50383-0968 |
|---|---|
| Product ID | 50383-968_ad35d691-3574-49cf-898c-b1cbd0c8f7bb |
| 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 | Akorn |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA208024 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 50383-0968-16 (50383096816)
| NDC Package Code | 50383-968-16 |
|---|---|
| Billing NDC | 50383096816 |
| Package | 1 BOTTLE, PUMP in 1 CARTON (50383-968-16) / 120 SPRAY, METERED in 1 BOTTLE, PUMP |
| Marketing Start Date | 2019-04-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL a778d891-b9e9-47d7-b474-4baca8be1dbd Details
Uses
Warnings
Only for use in the nose. Do not spray into your eyes or mouth.
Do Not Use
■ in children under 4 years of age
■ to treat asthma
■ if you have an injury or surgery to your nose that is not fully healed
■ if you have ever had an allergic reaction to this product or any of the ingredients
Ask a doctor or pharmacist before use if you are taking
■ medicine for HIV infection (such as ritonavir)
■ a steroid medicine for asthma, allergies or skin rash
■ ketoconazole pills (medicine for fungal infection)
When using this product
■ the growth rate of some children may be slower
■ stinging or sneezing may occur for a few seconds right after use
■do not share this bottle with anyone else as this may spread germs
■ remember to tell your doctor about all the medicines you take, including this one
Stop use and ask a doctor if
■ you have, or come into contact with someone who has, chicken pox, measles or tuberculosis
■ your symptoms do not get better within 7 days of starting use or you get new symptoms such as severe
facial pain or thick nasal discharge. You may have something more than allergies, such as an infection.
■ you get a constant whistling sound from your nose. This may be a sign of damage inside your nose.
■ you get an allergic reaction to this product. Seek medical help right away.
■ you get new changes to your vision that develop after starting this product
■ you have severe or frequent nosebleeds
Directions
■ read the Quick Start Guide for how to:
■ prime the bottle
■ use the spray
■ clean the spray nozzle
■ shake gently before each use
■ use this product only once a day
■ do not use more than directed
ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER
■ Week 1 – use 2 sprays in each nostril once daily
■ Week 2 through 6 months – use 1 or 2 sprays in each nostril once daily, as needed to treat your
symptoms
■ After 6 months of daily use – ask your doctor if you can keep using
CHILDREN 4 TO 11 YEARS OF AGE
■ the growth rate of some children may be slower while using this product. Children should use for the
shortest amount of time necessary to achieve symptom relief. Talk to your child’s doctor if your
child needs to use the spray for longer than two months a year.
■ an adult should supervise use
■ use 1 spray in each nostril once daily
CHILDREN UNDER 4 YEARS OF AGE
■ do not use
Other information
■ TAMPER EVIDENT: Do not use if plastic sleeve is torn or broken. Under the cap and nozzle, each
bottle has an aluminum seal around bottle neck. Do not use if any of these features are torn or
damaged.
■ you may start to feel relief the first day and full effect after several days of regular, once-a-day use
■ store between 4° and 30°C (39° and 86°F)
■ keep the label and enclosed materials. They contain important additional information.
Inactive Ingredients
Questions or comments
Call toll-free 1-800-262-9010 weekdays (9:00 am- 5:00 pm)
What problems can Fluticasone Propionate Nasal Spray help with?
Fluticasone Propionate Nasal Spray helps relieve a broad range of uncomfortable symptoms like congestion, runny nose, sneezing, itchy nose and itchy eyes.
These symptoms can be triggered by allergens like pollen, mold, dust and pet dander.
Manufactured by:
Hi-Tech Pharmacal Co., Inc.
Amityville, NY 11701
Rev.968:00 09/17
Package/Label Principal Display Panel
AKORN
* Compare to the active ingredient in Flonase®
NDC 50383-968-16
Fluticasone Propionate Nasal Spray (Glucocorticoid), 50 mcg Per Spray
Allergy Symptom Reliever Nasal Spray
24 Hour Relief of:
■ Itchy, Watery Eyes
■ Nasal Congestion
■ Runny Nose
■ Itchy Nose
■ Sneezing
NEW: FULL PRESCRIPTION STRENGTH
NON DROWSY
24 HOUR RELIEF
120 METERED SPRAYS
0.54 fl oz (15.8 mL)
INGREDIENTS AND APPEARANCE
| FLUTICASONE PROPIONATE
fluticasone propionate spray, metered |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Labeler - Akorn (117696873) |
| Registrant - Akorn Operating Company LLC (117693100) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn | 117696873 | MANUFACTURE(50383-968) | |