Human Thrombin Solution
NDC Package 67778-100-00

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.

Human Thrombin solution is a bulk ingredient utilized for pharmaceutical compounding or manufacturing. This formulation utilizes a solution delivery system. Marketed by Omrix Biopharmaceuticals Ltd, this product is identified by NDC 67778-100.

Identification & Billing

NDC Package Code
67778-100-00
Package Description
34 kg in 1 BAG
Product Code
67778-100
11-Digit Billing Format
67778010000

Clinical Specifications

Proprietary Name
Human Thrombin
Non-Proprietary Name
Human Thrombin
Substance Name
Human Thrombin
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Active Ingredient(s)
HUMAN THROMBIN 1 kg/kg

Regulatory & Marketing

Labeler Name
Omrix Biopharmaceuticals Ltd
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
09-19-2009
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 67778-100-00 identifies a specific commercial package of 34 kg in 1 bag of Human Thrombin (UNFINISHED drug), a bulk ingredient labeled by Omrix Biopharmaceuticals Ltd. This solution is formulated for use and contains human thrombin 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 Omrix Biopharmaceuticals Ltd on September 19, 2009. The current certification is valid through December 31, 2026.

How is this Omrix Biopharmaceuticals Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67778010000. 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)
67778-100-00
11-Digit CMS (5-4-2)
67778-0100-00

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