Ipratropium Bromide And Albuterol Sulfate Solution
NDC Package 65862-906-03

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

Package Information

Ipratropium Bromide And Albuterol Sulfate solution is ipratropium bromide and albuterol sulfate inhalation solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator. This formulation utilizes a solution delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 65862-906 and is authorized under FDA application ANDA206532.

Identification & Billing

NDC Package Code
65862-906-03
Package Description
30 POUCH in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-906-01) / 3 mL in 1 VIAL, SINGLE-DOSE
Product Code
65862-906
11-Digit Billing Format
65862090603
RxNorm Crosswalk
  • RxCUI: 1437702 - ipratropium Br 0.5 MG / albuterol sulfate 3 MG in 3 ML Inhalation Solution
  • RxCUI: 1437702 - albuterol 0.833 MG/ML / ipratropium bromide 0.167 MG/ML Inhalation Solution
  • RxCUI: 1437702 - albuterol 2.5 MG (as albuterol sulfate 3 MG) / ipratropium bromide 0.5 MG per 3 ML Inhalation Solution

Clinical Specifications

Proprietary Name
Ipratropium Bromide And Albuterol Sulfate
Non-Proprietary Name
Ipratropium Bromide And Albuterol Sulfate
Substance Name
Albuterol Sulfate; 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)
Pharmacologic Class
Usage Information
Ipratropium bromide and albuterol sulfate inhalation solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.

Regulatory & Marketing

Labeler Name
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA206532
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-09-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65862-906). Click a package code to view its specific billing and regulatory data.

65862-906-30
6 POUCH in 1 CARTON / 5 VIAL, SINGLE-DOSE in 1 POUCH (65862-906-05) / 3 mL in 1 VIAL, SINGLE-DOSE
65862-906-60
12 POUCH in 1 CARTON / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE

* 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 65862-906-03 identifies a specific commercial package of 30 pouch in 1 carton / 1 vial, single-dose in 1 pouch (65862-906-01) / 3 ml in 1 vial, single-dose of Ipratropium Bromide And Albuterol Sulfate, a human prescription drug labeled by Aurobindo Pharma Limited. This solution is formulated for respiratory (inhalation) use and contains albuterol sulfate; 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 Aurobindo Pharma Limited on July 09, 2020. The current certification is valid through December 31, 2026.

How is this Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65862090603. 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)
65862-906-03
11-Digit CMS (5-4-2)
65862-0906-03

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