NDC 50383-968 Fluticasone Propionate

Fluticasone Propionate

NDC Product Code 50383-968

NDC 50383-968-16

Package Description: 1 BOTTLE, PUMP in 1 CARTON > 120 SPRAY, METERED in 1 BOTTLE, PUMP

NDC 50383-968-18

Package Description: 1 BOTTLE, PUMP in 1 CARTON > 60 SPRAY, METERED in 1 BOTTLE, PUMP

NDC 50383-968-36

Package Description: 2 BOTTLE, PUMP in 1 CARTON > 60 SPRAY, METERED in 1 BOTTLE, PUMP

NDC 50383-968-37

Package Description: 2 BOTTLE, PUMP in 1 CARTON > 120 SPRAY, METERED in 1 BOTTLE, PUMP

NDC 50383-968-38

Package Description: 3 BOTTLE, PUMP in 1 CARTON > 120 SPRAY, METERED in 1 BOTTLE, PUMP

NDC Product Information

Fluticasone Propionate with NDC 50383-968 is a a human over the counter drug product labeled by Hi-tech Pharmacal Co., Inc.. The generic name of Fluticasone Propionate is fluticasone propionate. The product's dosage form is spray, metered and is administered via nasal form.

Labeler Name: Hi-tech Pharmacal Co., Inc.

Dosage Form: Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Fluticasone Propionate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • FLUTICASONE PROPIONATE 50 ug/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
  • PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Nasal - Administration to the nose; administered by way of the nose.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Hi-tech Pharmacal Co., Inc.
Labeler Code: 50383
FDA Application Number: ANDA208024 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 04-18-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Fluticasone Propionate Product Label Images

Fluticasone Propionate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Fluticasone propionate (glucocorticoid) 50 mcg (in each spray)

Purpose

Allergy symptom reliever

Uses

Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:■ nasal congestion■ runny nose■ sneezing■ itchy nose■itchy, watery eyes

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 Before Use If You

Have or had glaucoma or cataracts

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

Pregnancy Or Breast Feeding

Ask a health professional before use.

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

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 directedADULTS 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 usingCHILDREN 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 dailyCHILDREN 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

Benzalkonium chloride, carboxymethylcellulose sodium, dextrose, microcrystalline cellulose, phenylethyl alcohol, polysorbate 80, and purified water

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

* Please review the disclaimer below.

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