Budesonide .25 mg/2mL
Budesonide · SUSPENSION · Teva Pharmaceuticals USA, Inc.
Budesonide is a suspension containing budesonide at .25 mg/2mL, taken respiratory (inhalation). Manufactured by Teva Pharmaceuticals USA, Inc..
Key Facts
- Brand Name
- Budesonide
- Generic Name
- Budesonide
- NDC Code (Product)
0093-6815- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Strength
- .25 mg/2mL
- Dosage Form
- SUSPENSION
- Route
- RESPIRATORY (INHALATION)
- Marketing Status
- Application #
- ANDA077519
- Drug Class
- Corticosteroid [EPC]
- Marketing Start
- 01/11/2019
Recall History
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Golden State Medical Supply Inc.
Failed Dissolution Specifications
Teva Pharmaceuticals USA, Inc
Failed Dissolution Specifications
AsttraZeneca Pharmaceuticals LP
Defective delivery system
Cipla USA, Inc.
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Integrated Health Concepts Inc. dba Conversio Health
Lack of Processing Controls
Integrated Health Concepts Inc. dba Conversio Health
Lack of Processing Controls
Solutions Rx Pharmacy
Penicillin Cross Contamination - Possible presence of penicillin in bulk budesonide powder used to compound prescription nasal rinse/nebulizer capsules.
Reliable Rexall-A Compounding Pharmacy
Lack of Processing Controls
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Use s Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • itchy nose • sneezing
Dosage & Administration
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 eac…
Warnings
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).
Frequently Asked Questions
What is Budesonide used for?
Budesonide contains Budesonide. It is a suspension taken respiratory (inhalation). Consult your doctor for specific uses.
Is Budesonide a controlled substance?
Budesonide is not classified as a controlled substance by the DEA.
What is the generic name for Budesonide?
The generic name for Budesonide is Budesonide. There are 9 other brand versions of Budesonide.
What is the NDC code for Budesonide .25 mg/2mL?
The NDC (National Drug Code) for Budesonide .25 mg/2mL is 0093-6815, listed by Teva Pharmaceuticals USA, Inc..
Other Budesonide Dosages
Other Budesonide Brands
See all →- Budesonide and formoterol fumarate dihydrate80 ug/10480-3080
- budesonide3 mg/10574-9855
- SYMBICORT160 ug/150090-4509
- Budesonide Inhalation Suspension.5 mg/2mL68788-7314
- BREYNA160 ug/10378-7503
- budesonide3 mg/170771-1075
- Budesonide Inhalation.5 mg/2mL0115-1689
- PULMICORT RESPULES.25 mg/2mL0186-1988
- SYMBICORT160 ug/150090-1403
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)