Neomycin And Polymyxin B Sulfates Solution
NDC Package 39822-1201-2

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

Neomycin And Polymyxin B Sulfates solution is for Irrigation is indicated for short-term use (up to 10 days) as a continuous irrigant or rinse in the urinary bladder of abacteriuric patients to help prevent bacteriuria and gram-negative rod septicemia associated with the use of indwelling catheters.Since organisms gain entrance to the bladder by way of, through, and around the catheter, significant bacteriuria is induced by bacterial multiplication in the bladder urine, in the mucoid film often present between catheter and urethra, and in other sites. This formulation utilizes a solution delivery system. Marketed by Xgen Pharmaceuticals Djb, Inc., this product is identified by NDC 39822-1201 and is authorized under FDA application ANDA065106.

Identification & Billing

NDC Package Code
39822-1201-2
Package Description
10 AMPULE in 1 CARTON / 1 mL in 1 AMPULE (39822-1201-1)
Product Code
39822-1201
11-Digit Billing Format
39822120102
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 314124 - neomycin sulfate 40 MG / polymyxin B sulfate 200,000 UNT per mL Irrigation Solution
  • RxCUI: 314124 - neomycin 40 MG/ML / polymyxin B 200000 UNT/ML Irrigation Solution

Clinical Specifications

Proprietary Name
Neomycin And Polymyxin B Sulfates
Non-Proprietary Name
Neomycin And Polymyxin B Sulfates
Substance Name
Neomycin Sulfate; Polymyxin B Sulfate
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
Irrigation - Administration to bathe or flush open wounds or body cavities.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Neomycin and Polymyxin B Sulfates Solution for Irrigation is indicated for short-term use (up to 10 days) as a continuous irrigant or rinse in the urinary bladder of abacteriuric patients to help prevent bacteriuria and gram-negative rod septicemia associated with the use of indwelling catheters.Since organisms gain entrance to the bladder by way of, through, and around the catheter, significant bacteriuria is induced by bacterial multiplication in the bladder urine, in the mucoid film often present between catheter and urethra, and in other sites. Urinary tract infection may result from the repeated presence in the urine of large numbers of pathogenic bacteria. The use of closed systems with indwelling catheters has been shown to reduce the risk of infection. A three-way closed catheter system with constant neomycin-polymyxin B bladder rinse is indicated to prevent the development of infection while using indwelling catheters.If uropathogens are isolated, they should be identified and tested for susceptibility so that appropriate antimicrobial therapy for systemic use can be initiated.

Regulatory & Marketing

Labeler Name
Xgen Pharmaceuticals Djb, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA065106
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-19-2006
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (39822-1201). Click a package code to view its specific billing and regulatory data.

39822-1201-5
50 AMPULE in 1 CARTON / 1 mL in 1 AMPULE

* 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 39822-1201-2 identifies a specific commercial package of 10 ampule in 1 carton / 1 ml in 1 ampule (39822-1201-1) of Neomycin And Polymyxin B Sulfates, a human prescription drug labeled by Xgen Pharmaceuticals Djb, Inc.. This solution is formulated for irrigation use and contains neomycin sulfate; polymyxin b sulfate 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 Xgen Pharmaceuticals Djb, Inc. on January 19, 2006. The current certification is valid through December 31, 2027.

How is this Xgen Pharmaceuticals Djb, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 39822120102. 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)
39822-1201-2
11-Digit CMS (5-4-2)
39822-1201-02

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