1. Home
  2. Labeler Index
  3. Ethicon, Inc
  4. 63713-461
  5. NDC Package Code: 63713-461-02 Thrombin Human

NDC Package 63713-461-02 Thrombin Human

Powder, For Solution Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
63713-461-02
Package Description:
2 mL in 1 VIAL, GLASS
Product Code:
63713-461
Proprietary Name:
Thrombin Human
Non-Proprietary Name:
Thrombin Human
Substance Name:
Human Thrombin
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.
11-Digit NDC Billing Format:
63713046102
NDC to RxNorm Crosswalk:
  • RxCUI: 748321 - thrombin, human 1200 UNT in 1 mL Topical Solution
  • RxCUI: 748321 - thrombin, human 1200 UNT/ML Topical Solution
  • RxCUI: 748321 - thrombin, human 1200 UNT per 1 ML Topical Solution
    • Product Type:
    Plasma Derivative
    Labeler Name:
    Ethicon, Inc
    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(s):
  • 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(es):
  • Blood Coagulation Factors - [CS]
  • Human Blood Coagulation Factor - [EPC] (Established Pharmacologic Class)
  • Increased Coagulation Factor Activity - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    BLA125247
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    09-19-2009
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 63713-461-02?

    The NDC Packaged Code 63713-461-02 is assigned to a package of 2 ml in 1 vial, glass of Thrombin Human, a plasma derivative labeled by Ethicon, Inc. The product's dosage form is powder, for solution and is administered via topical form.

    Is NDC 63713-461 included in the NDC Directory?

    Yes, Thrombin Human with product code 63713-461 is active and included in the NDC Directory. The product was first marketed by Ethicon, Inc on September 19, 2009 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 63713-461-02?

    The 11-digit format is 63713046102. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-263713-461-025-4-263713-0461-02