NDC 0536-1112 Budesonide

Budesonide

  1. Labeler Index
  2. Rugby Laboratories
  3. NDC: 0536-1112 Budesonide

NDC Product Code 0536-1112

NDC CODE: 0536-1112

Proprietary Name: Budesonide 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.
Non-Proprietary Name: Budesonide 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
  • Budesonide is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. This medication belongs to a class of drugs known as corticosteroids. It works directly in the lungs to make breathing easier by reducing the irritation and swelling of the airways. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler as prescribed.

NDC Code Structure

NDC 0536-1112-40

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

NDC 0536-1112-48

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

NDC Product Information

Budesonide with NDC 0536-1112 is a a human over the counter drug product labeled by Rugby Laboratories. The generic name of Budesonide is budesonide. The product's dosage form is spray, metered and is administered via nasal form.

Labeler Name: Rugby Laboratories

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.

Budesonide 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.
  • BUDESONIDE 32 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.
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • DEXTROSE (UNII: IY9XDZ35W2)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • 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: Rugby Laboratories
Labeler Code: 0536
FDA Application Number: ANDA078949 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: 07-13-2016 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: 12-31-2021 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 - NO 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".

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Information for Patients

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]

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Budesonide Product Label Images

Budesonide 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 (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

Do Not Use

  • In children under 6 years of ageif 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 surgeryhave had a nose injury that has not healedare using a steroid medicine for asthma, allergies or skin rashhave an eye infectionhave or had glaucoma or cataracts

When Using This Product

  • The growth rate of some children may be slowersome 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 germsremember 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 tuberculosisyou have or develop symptoms of an infection such as persistent feveryou have any change in visionyou 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 useprime bottle again if not used for two daysuse the sprayclean the spray nozzleADULTS AND CHILDREN 12 YEARS OF AGE AND OLDERadults and children 12 years of age and olderonce daily, spray 2 times into each nostril while sniffing gentlyonce your allergy symptoms improve, reduce to 1 spray in each nostril per dayCHILDREN 6 TO UNDER 12 YEARS OF AGEthe 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 yearchildren 6 to under 12 years of agean adult should supervise useonce daily, spray 1 time into each nostril while sniffing gentlyif 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 daychildren under 6 years of agedo not usedo not use more than directedif you forget a dose, do not double the next dosedo not spray into eyes or mouthif allergy symptoms do not improve after two weeks, stop using and talk to a doctordo not use for the common coldshake 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

* Please review the disclaimer below.