Polymyxin B Injection, Powder, Lyophilized, For Solution
NDC Package 63323-367-44

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

Polymyxin B (polymyxin b sulfate) injection is acute Infections Caused by Susceptible Strains of Pseudomonas aeruginosa. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-367 and is authorized under FDA application ANDA202766.

Identification & Billing

NDC Package Code
63323-367-44
Package Description
10 VIAL, GLASS in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (63323-367-41)
Product Code
63323-367
11-Digit Billing Format
63323036744
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA
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
Non-Proprietary Name
Polymyxin B Sulfate
Substance Name
Polymyxin B Sulfate
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intrathecal - Administration within the cerebrospinal fluid at any level of the cerebrospinal axis, including injection into the cerebral ventricles.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
POLYMYXIN B SULFATE 500000 [USP'U]/1
Pharmacologic Class
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 blood-stream 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
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA202766
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-09-2015
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 (63323-367). Click a package code to view its specific billing and regulatory data.

63323-367-11
10 VIAL in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-367-01)

* 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 63323-367-44 identifies a specific commercial package of 10 vial, glass in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, glass (63323-367-41) of Polymyxin B, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 10 billable units per package. This injection, powder, lyophilized, for solution is formulated for intramuscular; intrathecal; intravenous use and contains 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 Fresenius Kabi Usa, Llc on September 09, 2015. The current certification is valid through December 31, 2026.

How is this Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63323036744. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 total billable units per package. 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)
63323-367-44
11-Digit CMS (5-4-2)
63323-0367-44

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