NDC Package 0143-9461-01 Polymyxin B

Polymyxin B Sulfate Injection, Powder, For Solution Intramuscular; Intrathecal; - View Billable Units, 11-Digit Format, RxNorm

Package Information
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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:

0143-9461-01

Package Description:

1 VIAL, GLASS in 1 CARTON / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS

Product Code:

0143-9461

Proprietary Name:

Polymyxin B

Non-Proprietary Name:

Polymyxin B Sulfate

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 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.

11-Digit NDC Billing Format:

00143946101

Billing Unit:

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

NDC to RxNorm Crosswalk:

1 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:

Hikma Pharmaceuticals Usa Inc.

Dosage Form:

Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.

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):

Sample Package:

FDA Application Number:

ANDA202766

Marketing Category:

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

Start Marketing Date:

09-30-2025

Listing Expiration Date:

12-31-2026

Exclude Flag:

Code Structure:

0143 - Hikma Pharmaceuticals Usa Inc.
- 0143-9461 - Polymyxin B
  - 0143-9461-01 - 1 VIAL, GLASS in 1 CARTON / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS

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.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
0143-9461-10	10 VIAL, GLASS in 1 CARTON / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0143-9461-01?

The NDC Packaged Code 0143-9461-01 is assigned to a package of 1 vial, glass in 1 carton / 1 injection, powder, for solution in 1 vial, glass of Polymyxin B, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is injection, powder, 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 1 billable units per package.

Is NDC 0143-9461 included in the NDC Directory?

Yes, Polymyxin B with product code 0143-9461 is active and included in the NDC Directory. The product was first marketed by Hikma Pharmaceuticals Usa Inc. on September 30, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0143-9461-01?

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 1.

What is the 11-digit format for NDC 0143-9461-01?

The 11-digit format is 00143946101. 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 4-4-2 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
4-4-2	0143-9461-01	5-4-2	00143-9461-01

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