Ipratropium Bromide Spray
NDC Package 69238-2016-3

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

Package Information

Ipratropium Bromide sprays 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 spray delivery system. Marketed by Amneal Pharmaceuticals Ny Llc, this product is identified by NDC 69238-2016 and is authorized under FDA application ANDA215104.

Identification & Billing

NDC Package Code
69238-2016-3
Package Description
1 BOTTLE, SPRAY in 1 CARTON / 345 SPRAY in 1 BOTTLE, SPRAY
Product Code
69238-2016
11-Digit Billing Format
69238201603
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1797833 - ipratropium Br 21 MCG/ACTUAT (0.03 % ) Metered Dose Nasal Spray
  • RxCUI: 1797833 - ipratropium bromide 0.021 MG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797833 - ipratropium bromide 21 MCG/ACTUAT Metered Dose Nasal Spray

Clinical Specifications

Proprietary Name
Ipratropium Bromide
Non-Proprietary Name
Ipratropium Bromide
Substance Name
Ipratropium Bromide
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
IPRATROPIUM BROMIDE 21 ug/1
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
Amneal Pharmaceuticals Ny Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA215104
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-18-2022
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 69238-2016-3 identifies a specific commercial package of 1 bottle, spray in 1 carton / 345 spray in 1 bottle, spray of Ipratropium Bromide, a human prescription drug labeled by Amneal Pharmaceuticals Ny Llc. This spray is formulated for nasal 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 Amneal Pharmaceuticals Ny Llc on August 18, 2022. 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 Amneal Pharmaceuticals Ny Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69238201603. 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:

10-Digit Format (5-4-1)
69238-2016-3
11-Digit CMS (5-4-2)
69238-2016-03

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