Ipratropium Bromide Spray, Metered
NDC Package 60505-0827-1

11-digit billing NDC: 60505082701 · Billing unit: ML
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Ipratropium Bromide sprays is ipratropium bromide nasal solution, 0.06% is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. Ipratropium bromide nasal solution, 0.06% does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. This formulation utilizes a spray, metered delivery system. Marketed by Apotex Corp., this product is identified by NDC 60505-0827 and is authorized under FDA application ANDA076155.

Identification & Billing

NDC Package Code
60505-0827-1
Package Description
1 BOTTLE, PUMP in 1 CARTON / 165 SPRAY, METERED in 1 BOTTLE, PUMP
Product Code
60505-0827
11-Digit Billing Format
60505082701
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1797844 - ipratropium Br 42 MCG/ACTUAT (0.06 % ) Metered Dose Nasal Spray
  • RxCUI: 1797844 - ipratropium bromide 0.042 MG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797844 - ipratropium bromide 0.06 % Metered Dose Nasal Spray
  • RxCUI: 1797844 - ipratropium bromide 42 MCG/ACTUAT Metered Dose Nasal Spray

Clinical Specifications

Proprietary Name
Ipratropium Bromide
Non-Proprietary Name
Ipratropium 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 42 ug/1
Pharmacologic Class
Usage Information
Ipratropium bromide nasal solution, 0.06% is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. Ipratropium bromide nasal solution, 0.06% does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. The safety and effectiveness of the use of ipratropium bromide nasal solution, 0.06% beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established.

Regulatory & Marketing

Labeler Name
Apotex Corp.
Product Type
Human Prescription Drug
FDA Application #
ANDA076155
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-26-2020
Listing Expiration
12-31-2027
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 60505-0827-1 identifies a specific commercial package of 1 bottle, pump in 1 carton / 165 spray, metered in 1 bottle, pump of Ipratropium Bromide, a human prescription drug labeled by Apotex Corp.. 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 Apotex Corp. on May 26, 2020. The current certification is valid through December 31, 2027.

How is this Apotex Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60505082701. 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)
60505-0827-1
11-Digit CMS (5-4-2)
60505-0827-01

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