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

Solution Respiratory (inhalation) - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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:
Proprietary Name:
Ipratropium Bromide And Albuterol Sulfate
Non-Proprietary Name:
Ipratropium Bromide And Albuterol Sulfate
Substance Name:
Albuterol Sulfate; Ipratropium Bromide
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.
11-Digit NDC Billing Format:
65862090603
NDC to 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
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Aurobindo Pharma Limited
    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(s):
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
  • Sample Package:
    No
    FDA Application Number:
    ANDA206532
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-09-2020
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    65862-906-306 POUCH in 1 CARTON / 5 VIAL, SINGLE-DOSE in 1 POUCH (65862-906-05) / 3 mL in 1 VIAL, SINGLE-DOSE
    65862-906-6012 POUCH in 1 CARTON / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65862-906-03?

    The NDC Packaged Code 65862-906-03 is assigned to a 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. The product's dosage form is solution and is administered via respiratory (inhalation) form.

    Is NDC 65862-906 included in the NDC Directory?

    Yes, Ipratropium Bromide And Albuterol Sulfate with product code 65862-906 is active and included in the NDC Directory. The product was first marketed by Aurobindo Pharma Limited on July 09, 2020 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 65862-906-03?

    The 11-digit format is 65862090603. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-265862-906-035-4-265862-0906-03