Polymyxin B Injection, Powder, Lyophilized, For Solution
NDC Package 68083-174-10

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

Package Information

Polymyxin B (polymyxin b sulfate) injection 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. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-174 and is authorized under FDA application ANDA207322.

Identification & Billing

NDC Package Code
68083-174-10
Package Description
10 VIAL in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (68083-174-01)
Product Code
68083-174
11-Digit Billing Format
68083017410
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.
  • Ophthalmic - Administration to the external eye.
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 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
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA207322
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-01-2016
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68083-174-10 identifies a specific commercial package of 10 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial (68083-174-01) of Polymyxin B, a human prescription drug labeled by Gland Pharma Limited. This injection, powder, lyophilized, for solution is formulated for intramuscular; intrathecal; intravenous; ophthalmic 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 Gland Pharma Limited on June 01, 2016. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083017410. 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)
68083-174-10
11-Digit CMS (5-4-2)
68083-0174-10

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