Ipratropium Bromide 21 ug/1
Ipratropium Bromide · SPRAY · Amneal Pharmaceuticals NY LLC
Ipratropium Bromide is a spray containing ipratropium bromide at 21 ug/1, taken nasal. Manufactured by Amneal Pharmaceuticals NY LLC.
Key Facts
- Brand Name
- Ipratropium Bromide
- Generic Name
- Ipratropium Bromide
- NDC Code (Product)
69238-2016- Manufacturer
- Amneal Pharmaceuticals NY LLC
- Strength
- 21 ug/1
- Dosage Form
- SPRAY
- Route
- NASAL
- Marketing Status
- Application #
- ANDA215104
- Marketing Start
- 08/18/2022
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Dispensing Solutions, Inc
Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indicates product name as Ventolin HFA 90 mcg instead of correctly as Atrovent HFA 12.9 grams Inhalation Aerosol
Cipla USA, Inc.
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Nephron Pharmaceuticals Corp.
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
CARDINAL HEALTHCARE
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Boehringer Ingelheim Roxane Inc
Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Full prescribing information not available for this product.
Frequently Asked Questions
What is Ipratropium Bromide used for?
Ipratropium Bromide contains Ipratropium Bromide. It is a spray taken nasal. Consult your doctor for specific uses.
Is Ipratropium Bromide a controlled substance?
Ipratropium Bromide is not classified as a controlled substance by the DEA.
What is the generic name for Ipratropium Bromide?
The generic name for Ipratropium Bromide is Ipratropium Bromide. There are 5 other brand versions of Ipratropium Bromide.
What is the NDC code for Ipratropium Bromide 21 ug/1?
The NDC (National Drug Code) for Ipratropium Bromide 21 ug/1 is 69238-2016, listed by Amneal Pharmaceuticals NY LLC.