Xaracoll
NDC Package 51715-100-04

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Xaracoll is indicated in adults for placement into the surgical site to produce postsurgical analgesia for up to 24 hours following open inguinal hernia repair.Limitations of UseSafety and effectiveness have not been established in other surgical procedures, including orthopedic and boney procedures [see Warnings and Precautions (5.5)]. Marketed by Innocoll Pharmaceuticals, this product is identified by NDC 51715-100 and is authorized under FDA application NDA209511.

Identification & Billing

NDC Package Code
51715-100-04
Package Description
4 CARTON in 1 CARTON / 1 POUCH in 1 CARTON / 3 IMPLANT in 1 POUCH
Product Code
51715-100
11-Digit Billing Format
51715010004
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Xaracoll
Dosage Form
-
Usage Information
XARACOLL is indicated in adults for placement into the surgical site to produce postsurgical analgesia for up to 24 hours following open inguinal hernia repair.Limitations of UseSafety and effectiveness have not been established in other surgical procedures, including orthopedic and boney procedures [see Warnings and Precautions (5.5)].

Regulatory & Marketing

Labeler Name
Innocoll Pharmaceuticals
FDA Application #
NDA209511
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-28-2020
Listing Expiration
12-31-2023
Exclude Flag
I
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (51715-100). Click a package code to view its specific billing and regulatory data.

51715-100-10
10 CARTON in 1 CARTON / 1 POUCH in 1 CARTON / 3 IMPLANT in 1 POUCH

* 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 51715-100-04 identifies a specific commercial package of 4 carton in 1 carton / 1 pouch in 1 carton / 3 implant in 1 pouch of Xaracoll, labeled by Innocoll Pharmaceuticals. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Innocoll Pharmaceuticals on August 28, 2020. The current certification is valid through December 31, 2023.

How is this Innocoll Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51715010004. 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)
51715-100-04
11-Digit CMS (5-4-2)
51715-0100-04

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