Ipratroprium Bromide Spray, Metered
NDC Package 68682-398-30

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

Package Information

Ipratroprium 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, metered delivery system. Marketed by Oceanside Pharmaceuticals, this product is identified by NDC 68682-398 and is authorized under FDA application ANDA076025.

Identification & Billing

NDC Package Code
68682-398-30
Package Description
1 BOTTLE, SPRAY in 1 CARTON / 345 SPRAY, METERED in 1 BOTTLE, SPRAY
Product Code
68682-398
11-Digit Billing Format
68682039830
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
Ipratroprium Bromide
Non-Proprietary Name
Ipratroprium Bromide
Substance Name
Ipratropium Bromide
Dosage Form
Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.
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 (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
Oceanside Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
ANDA076025
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-01-2025
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 68682-398-30 identifies a specific commercial package of 1 bottle, spray in 1 carton / 345 spray, metered in 1 bottle, spray of Ipratroprium Bromide, a human prescription drug labeled by Oceanside Pharmaceuticals. This spray, metered 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 Oceanside Pharmaceuticals on June 01, 2025. 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 Oceanside Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68682039830. 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 (5-3-2)
68682-398-30
11-Digit CMS (5-4-2)
68682-0398-30

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