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Budesonide

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Budesonide
Generic name
Budesonide
Dosage form
Spray, Metered
Route
Nasal
Marketing category
ANDA · ANDA
Labeler
Rugby Laboratories
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
6
Packages
8
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Budesonide 32 ug/1 1797929 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Spray, Metered
Route of administration
Nasal
Presentations
14

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Corticosteroid Hormone Receptor Agonists [MoA] MoA All 215 members
Corticosteroid [EPC] EPC All 215 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
078949
Application type
ANDA · Abbreviated New Drug Application
Approval date
May 12, 2014
Sponsor
APOTEX
Products on application
2
Submissions recorded
3
Products approved under application 078949.
Product Trade name Form Strength Ingredient Status TE Flags
078949-001 BUDESONIDE SPRAY, METERED BUDESONIDE Prescription —
078949-002 BUDESONIDE SPRAY, METERED BUDESONIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 078949.
Type No. Action Status Date Review
Supplement 10 Labeling Approved October 29, 2019 Standard
Supplement 3 Labeling Approved November 20, 2015 Standard
Original application 1 Approved May 12, 2014 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260227). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260227 HUMAN OTC DRUG · 20260121 HUMAN OTC DRUG · 20251209

Indications and Usage

openFDA Drug Labeling

Use s Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • itchy nose • sneezing

Purpose Nasal allergy symptom reliever

Dosage and Administration

openFDA Drug Labeling

Direction 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 yours 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 times 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

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 If pregnant 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 (1-800-222-1222).

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

openFDA Drug Labeling

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

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

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each spray) Budesonide (glucocorticoid) 32 mcg

Adverse event reports

Source: openFDA FAERS
164,264
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: BUDESONIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
60505-6129-2 60505-6129 Apotex Corp. 1 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (60505-6129-2) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY April 19, 2016
60505-6129-6 60505-6129 Apotex Corp. 2 BOTTLE, SPRAY in 1 CARTON (60505-6129-6) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY April 19, 2016
60505-6129-7 60505-6129 Apotex Corp. 3 BOTTLE, SPRAY in 1 CARTON (60505-6129-7) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY April 19, 2016
69842-001-01 69842-001 CVS Pharmacy 1 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (69842-001-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY July 1, 2025
49035-703-01 49035-703 EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 1 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (49035-703-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY July 1, 2025
0536-1112-48 0536-1112 Rugby Laboratories 1 BOTTLE, SPRAY in 1 CARTON (0536-1112-48) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY July 27, 2016
0536-1456-84 0536-1456 Rugby Laboratories 1 BOTTLE, SPRAY in 1 CARTON (0536-1456-84) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY December 1, 2025
0363-0048-01 0363-0048 Walgreens 1 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (0363-0048-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY July 1, 2025
60505-6129 60505-6129 Apotex Corp. — April 19, 2016
69842-001 69842-001 CVS Pharmacy — July 1, 2025
49035-703 49035-703 EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) — July 1, 2025
0536-1112 0536-1112 Rugby Laboratories — July 27, 2016
0536-1456 0536-1456 Rugby Laboratories — December 1, 2025
0363-0048 0363-0048 Walgreens — July 1, 2025

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.