Ipratropium Bromide Solution
NDC Package 68071-3769-2

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

Package Information

Ipratropium Bromide solution 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 solution delivery system. Marketed by Nucare Pharmaceuticals, Inc., this product is identified by NDC 68071-3769 and is authorized under FDA application ANDA075693.

Identification & Billing

NDC Package Code
68071-3769-2
Package Description
25 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE
Product Code
68071-3769
11-Digit Billing Format
68071376902
RxNorm Crosswalk
  • 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

Proprietary Name
Ipratropium Bromide
Non-Proprietary Name
Ipratropium Bromide
Substance Name
Ipratropium Bromide
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
IPRATROPIUM BROMIDE .5 mg/2.5mL
Pharmacologic Class
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 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.

Regulatory & Marketing

Labeler Name
Nucare Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA075693
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-09-2010
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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 68071-3769-2 identifies a specific commercial package of 25 ampule in 1 pouch / 2.5 ml in 1 ampule of Ipratropium Bromide, a human prescription drug labeled by Nucare Pharmaceuticals, Inc.. This solution is formulated for respiratory (inhalation) 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 Nucare Pharmaceuticals, Inc. on November 09, 2010. 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 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 Nucare Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071376902. 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)
68071-3769-2
11-Digit CMS (5-4-2)
68071-3769-02

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