Coagulation Factor Ix Recombinant Human Liquid
NDC Package 58394-789-99

11-digit billing NDC: 58394078999
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 Human liquids is a bulk ingredient utilized for pharmaceutical compounding or manufacturing. This formulation utilizes a liquid delivery system. Marketed by Wyeth Biopharma Division Of Wyeth Pharmaceuticals Llc, this product is identified by NDC 58394-789.

Identification & Billing

NDC Package Code
58394-789-99
Package Description
101 kg in 1 BOTTLE
Product Code
58394-789
11-Digit Billing Format
58394078999

Clinical Specifications

Proprietary Name
Coagulation Factor Ix Recombinant Human
Non-Proprietary Name
Coagulation Factor Ix Recombinant Human
Substance Name
Coagulation Factor Ix Recombinant Human
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Active Ingredient(s)
COAGULATION FACTOR IX RECOMBINANT HUMAN 1 kg/kg

Regulatory & Marketing

Labeler Name
Wyeth Biopharma Division Of Wyeth Pharmaceuticals Llc
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
02-01-1997
Listing Expiration
12-31-2027
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 58394-789-99 identifies a specific commercial package of 101 kg in 1 bottle of Coagulation Factor Ix Recombinant Human (UNFINISHED drug), a bulk ingredient labeled by Wyeth Biopharma Division Of Wyeth Pharmaceuticals Llc. This liquid 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 Wyeth Biopharma Division Of Wyeth Pharmaceuticals Llc on February 01, 1997. The current certification is valid through December 31, 2027.

How is this Wyeth Biopharma Division Of Wyeth Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58394078999. 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)
58394-789-99
11-Digit CMS (5-4-2)
58394-0789-99

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