Coagulation Factor Ix (recombinant) Powder
NDC Package 68225-059-00

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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.

Coagulation Factor Ix (recombinant) powders is a drug for further processing. This formulation utilizes a powder delivery system. Marketed by Patheon Italia S.p.a, this product is identified by NDC 68225-059.

Identification & Billing

NDC Package Code
68225-059-00
Package Description
1152 VIAL in 1 CONTAINER / 5 mL in 1 VIAL
Product Code
68225-059
11-Digit Billing Format
68225005900

Clinical Specifications

Proprietary Name
Coagulation Factor Ix (recombinant)
Non-Proprietary Name
Coagulation Factor Ix (recombinant)
Substance Name
Coagulation Factor Ix Recombinant Human
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
COAGULATION FACTOR IX RECOMBINANT HUMAN 500 [iU]/5mL

Regulatory & Marketing

Labeler Name
Patheon Italia S.p.a
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
05-12-2017
Listing Expiration
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68225-059-00 identifies a specific commercial package of 1152 vial in 1 container / 5 ml in 1 vial of Coagulation Factor Ix (recombinant) (UNFINISHED drug), drug for further processing labeled by Patheon Italia S.p.a. This powder is formulated for use and contains coagulation factor ix recombinant human 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 Italia S.p.a on May 12, 2017. The current certification is valid through December 31, 2026.

How is this Patheon Italia S.p.a product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68225005900. 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)
68225-059-00
11-Digit CMS (5-4-2)
68225-0059-00

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