Ipratropium Bromide Powder
NDC Package 43898-0102-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Ipratropium Bromide powders 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). This formulation utilizes a powder delivery system. Marketed by Lusochimica Spa, this product is identified by NDC 43898-0102.

Identification & Billing

NDC Package Code
43898-0102-0
Package Description
25 kg in 1 DRUM
Product Code
43898-0102
11-Digit Billing Format
43898010200

Clinical Specifications

Proprietary Name
Ipratropium Bromide
Non-Proprietary Name
Ipratropium Bromide
Substance Name
Ipratropium Bromide
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
IPRATROPIUM BROMIDE 1 kg/kg
Usage Information
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 (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 inhaler, but may sometimes be used to relieve symptoms of wheezing or sudden shortness of breath if so prescribed by your doctor.

Regulatory & Marketing

Labeler Name
Lusochimica Spa
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
02-15-1991
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

Hierarchy Structure

Code Lineage

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 43898-0102-0 identifies a specific commercial package of 25 kg in 1 drum of Ipratropium Bromide (UNFINISHED drug), a bulk ingredient labeled by Lusochimica Spa. This powder is formulated for use and contains ipratropium bromide as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Lusochimica Spa on February 15, 1991. The current certification is valid through December 31, 2026.

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 (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 inhaler, but may sometimes be used to relieve symptoms of wheezing or sudden shortness of breath if so prescribed by your doctor.

How is this Lusochimica Spa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43898010200. 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:

10-Digit Format (5-4-1)
43898-0102-0
11-Digit CMS (5-4-2)
43898-0102-00

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.