Evarrest Patch
NDC Package 63713-050-24

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Evarrest (fibrinogen human and human thrombin) patches is eVARREST® is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis in adult patients undergoing surgery, when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. This formulation utilizes a patch delivery system. Marketed by Ethicon, Inc., this product is identified by NDC 63713-050 and is authorized under FDA application BLA125392.

Identification & Billing

NDC Package Code
63713-050-24
Package Description
2 POUCH in 1 CARTON / 1 TRAY in 1 POUCH (63713-050-25) / 52 cm2 in 1 TRAY
Product Code
11-Digit Billing Format
63713005024
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
2 EA
RxNorm Crosswalk
  • RxCUI: 1793130 - fibrinogen / thrombin (human) 2 inch x 4 inch Medicated Patch
  • RxCUI: 1793130 - fibrinogen, human 444 MG / thrombin, human 1935 UNT Medicated Patch
  • RxCUI: 1793130 - fibrinogen, human / thrombin, human 2 inch x 4 inch Medicated Patch
  • RxCUI: 1793135 - EVARREST 2 inch x 4 inch Medicated Patch
  • RxCUI: 1793135 - fibrinogen, human 444 MG / thrombin, human 1935 UNT Medicated Patch [EVARREST]

Clinical Specifications

Proprietary Name
Evarrest
Non-Proprietary Name
Fibrinogen Human And Human Thrombin
Substance Name
Fibrinogen Human; Human Thrombin
Dosage Form
Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
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.
Usage Information
EVARREST® is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis in adult patients undergoing surgery, when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.

Regulatory & Marketing

Labeler Name
Ethicon, Inc.
Product Type
Plasma Derivative
FDA Application #
BLA125392
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-01-2013
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 63713-050-24 identifies a specific commercial package of 2 pouch in 1 carton / 1 tray in 1 pouch (63713-050-25) / 52 cm2 in 1 tray of Evarrest, a plasma derivative labeled by Ethicon, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 2 billable units per package. This patch is formulated for topical use and contains fibrinogen human; 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 March 01, 2013. 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: 63713005024. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2 total billable units per package. 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)
63713-050-24
11-Digit CMS (5-4-2)
63713-0050-24

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