Thrombin Human Powder, For Solution
NDC Package 63713-461-02

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

Package Information

Thrombin Human powders is eVITHROM® Thrombin, Topical (Human), is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.EVITHROM® Thrombin, Topical (Human), may be used in conjunction with an Absorbable Gelatin Sponge, USP. This formulation utilizes a powder, for solution delivery system. Marketed by Ethicon, Inc, this product is identified by NDC 63713-461 and is authorized under FDA application BLA125247.

Identification & Billing

NDC Package Code
63713-461-02
Package Description
2 mL in 1 VIAL, GLASS
Product Code
63713-461
11-Digit Billing Format
63713046102
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Thrombin Human
Non-Proprietary Name
Thrombin Human
Substance Name
Human Thrombin
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
HUMAN THROMBIN 2000 [iU]/2mL
Pharmacologic Class
Usage Information
EVITHROM® Thrombin, Topical (Human), is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.EVITHROM® Thrombin, Topical (Human), may be used in conjunction with an Absorbable Gelatin Sponge, USP.

Regulatory & Marketing

Labeler Name
Ethicon, Inc
Product Type
Plasma Derivative
FDA Application #
BLA125247
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
09-19-2009
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 63713-461-02 identifies a specific commercial package of 2 ml in 1 vial, glass of Thrombin Human, a plasma derivative labeled by Ethicon, Inc. This powder, for solution is formulated for topical 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 Ethicon, Inc on September 19, 2009. The current certification is valid through December 31, 2026.

How is this Ethicon, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63713046102. 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)
63713-461-02
11-Digit CMS (5-4-2)
63713-0461-02

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