Coly-mycin Injection
NDC Package 42023-107-06

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

Coly-mycin (colistimethate) injection is coly-Mycin M Parenteral is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. This formulation utilizes a injection delivery system. Marketed by Par Health Usa, Llc, this product is identified by NDC 42023-107 and is authorized under FDA application NDA050108.

Identification & Billing

NDC Package Code
42023-107-06
Package Description
6 VIAL in 1 CARTON / 2 mL in 1 VIAL
Product Code
42023-107
11-Digit Billing Format
42023010706
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Coly-mycin M
Non-Proprietary Name
Colistimethate
Substance Name
Colistimethate Sodium
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
COLISTIMETHATE SODIUM 150 mg/2mL
Pharmacologic Class
Usage Information
Coly-Mycin M Parenteral is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa. This antibiotic is not indicated for infections due to Proteus or Neisseria. Coly-Mycin M Parenteral has proven clinically effective in treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa. Coly-Mycin M Parenteral may be used to initiate therapy in serious infections that are suspected to be due to gram-negative organisms and in the treatment of infections due to susceptible gram-negative pathogenic bacilli.To reduce the development of drug-resistant bacteria and maintain the effectiveness of Coly-Mycin M and other antibacterial drugs, Coly-Mycin M 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
Par Health Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA050108
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-01-2007
End Marketing Date
05-31-2027
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 (42023-107). Click a package code to view its specific billing and regulatory data.

42023-107-01
1 VIAL in 1 CARTON / 2 mL in 1 VIAL

* 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 42023-107-06 identifies a specific commercial package of 6 vial in 1 carton / 2 ml in 1 vial of Coly-mycin M, a human prescription drug labeled by Par Health Usa, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection is formulated for intramuscular; intravenous use and contains colistimethate sodium 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 Par Health Usa, Llc on November 01, 2007.

How is this Par Health Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42023010706. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
42023-107-06
11-Digit CMS (5-4-2)
42023-0107-06

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