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  5. NDC Package Code: 68083-174-10 Polymyxin B

NDC Package 68083-174-10 Polymyxin B

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

Table of Contents

    1. Package Information
    2. 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:
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
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 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:
68083017410
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:
    Gland Pharma Limited
    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:
    No
    FDA Application Number:
    ANDA207322
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-01-2016
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 68083-174-10?

    The NDC Packaged Code 68083-174-10 is assigned to a 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. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intramuscular; intrathecal; intravenous; ophthalmic form.

    Is NDC 68083-174 included in the NDC Directory?

    Yes, Polymyxin B with product code 68083-174 is active and included in the NDC Directory. The product was first marketed by Gland Pharma Limited on June 01, 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 11-digit format for NDC 68083-174-10?

    The 11-digit format is 68083017410. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-268083-174-105-4-268083-0174-10