NDC Package 55150-234-10 Polymyxin B

Injection, Powder, Lyophilized, For Solution Intramuscular; Intrathecal; Intravenous; - View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

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:

55150-234-10

Package Description:

10 VIAL in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Product Code:

55150-234

Proprietary Name:

Polymyxin B

Non-Proprietary Name:

Polymyxin B

Substance Name:

Polymyxin B Sulfate

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.

11-Digit NDC Billing Format:

55150023410

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

10 EA

NDC to RxNorm Crosswalk:

RxCUI: 204509 - polymyxin B Variable Concentration Multi-Use Injectable Solution

RxCUI: 204509 - polymyxin B 250000 UNT/ML Injectable Solution

Product Type:

Human Prescription Drug

Labeler Name:

Eugia Us Llc

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(s):

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(es):

Polymyxin-class Antibacterial - [EPC] (Established Pharmacologic Class)

Polymyxins - [CS]

Sample Package:

FDA Application Number:

ANDA206589

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

04-04-2016

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

55150 - Eugia Us Llc
- 55150-234 - Polymyxin B
  - 55150-234-10 - 10 VIAL in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

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.

Frequently Asked Questions

What is NDC 55150-234-10?

The NDC Packaged Code 55150-234-10 is assigned to a package of 10 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial of Polymyxin B, a human prescription drug labeled by Eugia Us Llc. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intramuscular; intrathecal; intravenous; ophthalmic form.This product is billed for "EA" each discreet unit and contains an estimated amount of 10 billable units per package.

Is NDC 55150-234 included in the NDC Directory?

Yes, Polymyxin B with product code 55150-234 is active and included in the NDC Directory. The product was first marketed by Eugia Us Llc on April 04, 2016 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 NDC billing unit for package 55150-234-10?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 10.

What is the 11-digit format for NDC 55150-234-10?

The 11-digit format is 55150023410. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	55150-234-10	5-4-2	55150-0234-10

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