Beclomethasone Dipropionate 80 ug/1
Beclomethasone Dipropionate · AEROSOL, METERED · Amneal Pharmaceuticals NY LLC
Beclomethasone Dipropionate is a aerosol, metered containing beclomethasone dipropionate at 80 ug/1, taken respiratory (inhalation). Manufactured by Amneal Pharmaceuticals NY LLC.
Key Facts
- Brand Name
- Beclomethasone Dipropionate
- Generic Name
- Beclomethasone Dipropionate
- NDC Code (Product)
69238-1290- Manufacturer
- Amneal Pharmaceuticals NY LLC
- Strength
- 80 ug/1
- Dosage Form
- AEROSOL, METERED
- Route
- RESPIRATORY (INHALATION)
- Marketing Status
- Application #
- ANDA213811
- Marketing Start
- 12/17/2025
Recall History
Teva Pharmaceuticals USA
Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves.
Teva Pharmaceuticals USA
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.
Teva Pharmaceuticals USA
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Teva Pharmaceuticals USA
Defective Delivery System; defective valve
Teva North America
Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.
Teva Pharmaceuticals USA
Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Beclomethasone dipropionate HFA inhalation aerosol is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. Important Limitations of Use: Beclomethasone dipropionate HFA inhalation aerosol is NOT indicated for the relief of acute bronchospasm. Beclomethasone dipropionate HFA inhalation aerosol is a corticosteroid indicated for: Maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. (1) Important Limitations: Not indicated for the relief of acute bronchospasm. (1)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For oral inhalation only. (2.1) Starting dosage is based on prior asthma therapy and disease severity. (2.2) Treatment of asthma in patients 12 years and older: 40 mcg, 80 mcg, 160 mcg, or 320 mcg twice daily. (2.2) Treatment of asthma in patients 5 to 11 years of age: 40 or 80 mcg twice daily. (2.2) Discard beclomethasone dipropionate HFA inhalation aerosol inhaler when the dose counter displays 0 or after the expiration date on the product, whichever comes first. (2.1) 2.1 Administration Information Administer beclomethasone dipropionate HFA inhalation aerosol by the orally inhaled route in patients 5 years of age and older. Beclomethasone dipropionate HFA inhalation aerosol does not require shaking prior to use. After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis. Use of beclomethasone dipropionate HFA inhalation aerosol with a spacer device in children less than 5 years of age is not recommended [see Use in Specific Populations (8.4) ] . Patients should be instructed on the proper use of their inhaler. Consistent dose delivery is achieved, whether using the 40 or …
Contraindications
4 CONTRAINDICATIONS Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. (4) Hypersensitivity to any of the ingredients of beclomethasone dipropionate HFA inhalation aerosol. (4) 4.1 Status Asthmaticus Beclomethasone dipropionate HFA inhalation aerosol is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. 4.2 Hypersensitivity Beclomethasone dipropionate HFA inhalation aerosol is contraindicated in patients with known hypersensitivity to beclomethasone dipropionate or any of the ingredients in beclomethasone dipropionate HFA inhalation aerosol [see Warnings and Precautions (5.6) ] .
Adverse Reactions
6 ADVERSE REACTIONS Systemic and local corticosteroid use may result in the following: Candida albicans infection [see Warnings and Precautions (5.1) ] Immunosuppression [see Warnings and Precautions (5.4) ] Hypercorticism and adrenal suppression [see Warnings and Precautions (5.7) ] Growth effects [see Warnings and Precautions (5.8) and Use in Specific Populations (8.4) ] Eye Disorders [see Warnings and Precautions (5.10) ] Most common adverse reactions (incidence ≥3% and > placebo) include headache, pharyngitis, oral symptoms (inhalation route), and sinusitis. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following reporting rates of common adverse experiences are based upon 4 clinical trials in which 1196 patients (671 female and 525 male adults previously treated with as-needed bronchodil…
Frequently Asked Questions
What is Beclomethasone Dipropionate used for?
Beclomethasone Dipropionate contains Beclomethasone Dipropionate. It is a aerosol, metered taken respiratory (inhalation). Consult your doctor for specific uses.
Is Beclomethasone Dipropionate a controlled substance?
Beclomethasone Dipropionate is not classified as a controlled substance by the DEA.
What is the generic name for Beclomethasone Dipropionate?
The generic name for Beclomethasone Dipropionate is Beclomethasone Dipropionate. There are 8 other brand versions of Beclomethasone Dipropionate.
What is the NDC code for Beclomethasone Dipropionate 80 ug/1?
The NDC (National Drug Code) for Beclomethasone Dipropionate 80 ug/1 is 69238-1290, listed by Amneal Pharmaceuticals NY LLC.