Colistimethate Sodium Injection, Powder, Lyophilized, For Solution
NDC Package 63552-010-01

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

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Colistimethate Sodium injection is a drug for further processing. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Patheon Manufacturing Services Llc, this product is identified by NDC 63552-010.

Identification & Billing

NDC Package Code
63552-010-01
Package Description
288 VIAL, GLASS in 1 CASE / 6 mL in 1 VIAL, GLASS
Product Code
63552-010
11-Digit Billing Format
63552001001

Clinical Specifications

Proprietary Name
Colistimethate Sodium
Non-Proprietary Name
Colistimethate Sodium
Substance Name
Colistimethate Sodium
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.
Active Ingredient(s)
COLISTIMETHATE SODIUM 150 mg/6mL

Regulatory & Marketing

Labeler Name
Patheon Manufacturing Services Llc
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
01-01-2011
End Marketing Date
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (63552-010). Click a package code to view its specific billing and regulatory data.

63552-010-02
100 VIAL, GLASS in 1 CASE / 6 mL in 1 VIAL, GLASS
63552-010-03
120 VIAL, GLASS in 1 CASE / 6 mL in 1 VIAL, GLASS

* 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 63552-010-01 identifies a specific commercial package of 288 vial, glass in 1 case / 6 ml in 1 vial, glass of Colistimethate Sodium (UNFINISHED drug), drug for further processing labeled by Patheon Manufacturing Services Llc. This injection, powder, lyophilized, for solution is formulated for 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 Patheon Manufacturing Services Llc on January 01, 2011.

How is this Patheon Manufacturing Services Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63552001001. 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)
63552-010-01
11-Digit CMS (5-4-2)
63552-0010-01

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