Polymyxin B
NDC Package 45932-0030-1

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Polymyxin B is acute Infections Caused by Susceptible Strains of Pseudomonas aeruginosa.Polymyxin B sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of Ps. Marketed by Xellia Pharmaceuticals Aps, this product is identified by NDC 45932-0030 and is authorized under FDA application ANDA202766.

Identification & Billing

NDC Package Code
45932-0030-1
Package Description
10 VIAL in 1 CARTON / 1 INJECTION in 1 VIAL
Product Code
45932-0030
11-Digit Billing Format
45932003001
RxNorm Crosswalk
  • RxCUI: 204509 - polymyxin B Variable Concentration Multi-Use Injectable Solution
  • RxCUI: 204509 - polymyxin B 250000 UNT/ML Injectable Solution

Clinical Specifications

Proprietary Name
Polymyxin B
Dosage Form
-
Usage Information
Acute Infections Caused by Susceptible Strains of Pseudomonas aeruginosa.Polymyxin B sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of Ps. aeruginosa. It may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of Ps. aeruginosa. It may be indicated in serious infections caused by susceptible strains of the following organisms, when less potentially toxic drugs are ineffective or contraindicated:H influenzae, specifically meningeal infections.Escherichia coli, specifically urinary tract infections.Aerobacter aerogenes, specifically bacteremia.Klebsiella pneumoniae, specifically bacteremia.NOTE: IN MENINGEAL INFECTIONS, POLYMYXIN B SULFATE SHOULD BE ADMINISTERED ONLY BY THE INTRATHECAL ROUTE.To reduce the development of drug-resistant bacteria and maintain the effectiveness of polymyxin B and other antibacterial drugs, polymyxin B should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Regulatory & Marketing

Labeler Name
Xellia Pharmaceuticals Aps
FDA Application #
ANDA202766
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-24-2014
Listing Expiration
12-31-2019
Exclude Flag
I
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 45932-0030-1 identifies a specific commercial package of 10 vial in 1 carton / 1 injection in 1 vial of Polymyxin B, labeled by Xellia Pharmaceuticals Aps. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Xellia Pharmaceuticals Aps on January 24, 2014. The current certification is valid through December 31, 2019.

How is this Xellia Pharmaceuticals Aps product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45932003001. 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)
45932-0030-1
11-Digit CMS (5-4-2)
45932-0030-01

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