Ipratropium Bromide
NDC Package 54868-4082-0
Package Information
Ipratropium Bromide is ipratropium is used to control and prevent symptoms (wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD which includes bronchitis and emphysema). Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4082 and is authorized under FDA application ANDA074755.
Identification & Billing
- RxCUI: 836358 - ipratropium bromide 0.02 % Inhalation Solution
- RxCUI: 836358 - ipratropium bromide 0.2 MG/ML Inhalation Solution
- RxCUI: 836358 - ipratropium bromide 0.5 MG per 2.5 ML Inhalation Solution
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 54868 - Physicians Total Care, Inc.
- 54868-4082 - Ipratropium Bromide
- 54868-4082-0 - 12 POUCH in 1 CARTON / 5 VIAL in 1 POUCH / 2.5 mL in 1 VIAL
- 54868-4082 - Ipratropium Bromide
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
* Please review the full disclaimer at the bottom of this page.
Other Available Packages
The following commercial packages are registered under the same Product NDC (54868-4082). Click a package code to view its specific billing and regulatory data.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 54868-4082-0 identifies a specific commercial package of 12 pouch in 1 carton / 5 vial in 1 pouch / 2.5 ml in 1 vial of Ipratropium Bromide, labeled by Physicians Total Care, Inc.. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Physicians Total Care, Inc. on December 03, 1998. The current certification is valid through December 31, 2017.
What are the primary indications for this medication?
Ipratropium is used to control and prevent symptoms (wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD which includes bronchitis and emphysema). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Controlling symptoms of breathing problems can decrease time lost from work or school. For preventing symptoms of lung disease, this medication must be used regularly to be effective. Use your quick-relief inhaler or nebulized solution (such as albuterol, also called salbutamol in some countries) for wheezing or sudden shortness of breath unless otherwise directed by your doctor. Ipratropium does not work as fast as your quick-relief medication, but may sometimes be used together with your quick-relief medication to relieve symptoms of wheezing or sudden shortness of breath if so prescribed by your doctor.
How is this Physicians Total Care, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868408200. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.