NDC 0536-1112 Budesonide
Spray, Metered Nasal

Product Information

What is NDC 0536-1112?

The NDC code 0536-1112 is assigned by the FDA to the product Budesonide which is a human over the counter drug product labeled by Rugby Laboratories. The product's dosage form is spray, metered and is administered via nasal form. The product is distributed in 2 packages with assigned NDC codes 0536-1112-40 1 bottle, spray in 1 carton / 60 spray, metered in 1 bottle, spray, 0536-1112-48 1 bottle, spray in 1 carton / 120 spray, metered in 1 bottle, spray. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0536-1112
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Budesonide
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Budesonide
Product Type 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.
Human Otc Drug
Dosage FormSpray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.
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.
Rugby Laboratories
Labeler Code0536
FDA Application Number 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.
ANDA078949
Marketing Category 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.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
07-13-2016
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Budesonide?


Product Packages

NDC Code 0536-1112-40

Package Description: 1 BOTTLE, SPRAY in 1 CARTON / 60 SPRAY, METERED in 1 BOTTLE, SPRAY

NDC Code 0536-1112-48

Package Description: 1 BOTTLE, SPRAY in 1 CARTON / 120 SPRAY, METERED in 1 BOTTLE, SPRAY

Price per Unit: $1.59462 per ML

Product Details

What are Budesonide Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • BUDESONIDE 32 ug/1 - A glucocorticoid used in the management of ASTHMA, the treatment of various skin disorders, and allergic RHINITIS.

Budesonide Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Budesonide Inactive Ingredients UNII Codes

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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Patient Education

Budesonide Nasal Spray

Budesonide Nasal Spray is pronounced as (byoo des' oh nide)

Why is budesonide nasal spray medication prescribed?
Budesonide nasal spray is used to relieve sneezing, runny, stuffy, or itchy nose caused by hay fever or other allergies (caused by an allergy to pollen, mold, dust, or pe...
[Read More]

* Please review the disclaimer below.

Budesonide Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredient (In Each Spray)



Budesonide (glucocorticoid) 32 mcg


Purpose



Nasal allergy symptom reliever


Uses



Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

• nasal congestion • runny nose • itchy nose • sneezing


Warnings




Do Not Use



  • in children under 6 years of age
  • if you have ever had an allergic reaction to any of the ingredients

Ask A Doctor Before Use If You



  • have had recent nose ulcers or nose surgery
  • have had a nose injury that has not healed
  • are using a steroid medicine for asthma, allergies or skin rash
  • have an eye infection
  • have or had glaucoma or cataracts

When Using This Product



  • the growth rate of some children may be slower
  • some symptoms may get better on the first day of treatment. It may take up to two weeks of daily use to feel the most symptom relief.
  • 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, chickenpox, measles or tuberculosis
  • you have or develop symptoms of an infection such as persistent fever
  • you have any change in vision
  • you have severe or frequent nosebleeds

Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Directions



Read insert (inside package) on how to:
  • get a new bottle ready (primed) before first use
  • prime bottle again if not used for two days
  • use the spray
  • clean the spray nozzle

  • ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER

    adults and children 12 years of age and older

    • once daily, spray 2 times into each nostril while sniffing gently
    • once your allergy symptoms improve, reduce to 1 spray in each nostril per day
    CHILDREN 6 TO UNDER 12 YEARS OF AGE
    • the growth rate of some children may be slower while using this product. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year
    children 6 to under 12 years of age
    • an adult should supervise use
    • once daily, spray 1 time into each nostril while sniffing gently
    • if allergy symptoms do not improve, increase to 2 sprays in each nostril per day. Once allergy symptoms improve, reduce to 1 spray in each nostril per day
    children under 6 years of age
    • do not use
    • do not use more than directed
    • if you forget a dose, do not double the next dose
    • do not spray into eyes or mouth
    • if allergy symptoms do not improve after two weeks, stop using and talk to a doctor
    • do not use for the common cold
    • shake well before each use

Other Information



  • do not use if the safety seal labeled "sealed for your protection" is broken or missing.
  • keep package and insert. They contain important information.
  • store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light.

Inactive Ingredients



carboxymethyl cellulose sodium, dextrose anhydrous, edetate disodium dihydrate, hydrochloric acid (for pH adjustment), microcrystalline cellulose, polysorbate 80, potassium sorbate, purified water


Questions Or Comments?



call toll free 1-800-706-5575


Principal Display Panel - Carton 60Ms



CARTON LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray

Rugby Laboratories NDC 0536-1112-40

Budesonide Nasal Spray

Allergy Spray

60 sprays

Relief of:

Principal Display Panel - Carton 120Ms



CARTON LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray

Rugby Laboratories NDC 0536-1112-48

Budesonide Nasal Spray

Allergy Spray

120 sprays

Relief of:

  • Nasal Congestion
  • Runny Nose
  • Itchy Nose
  • Sneezing

Principal Display Panel - Bottle 60Ms



BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray

Rugby Laboratories NDC 0536-1112-40

Budesonide Nasal Spray

Allergy Spray

60 sprays


Principal Display Panel - Bottle 120Ms



BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray

Rugby Laboratories NDC 0536-1112-48

Budesonide Nasal Spray

Allergy Spray

120 sprays


* Please review the disclaimer below.