Elyxyb - Celecoxib
NDC Package 59385-055-22

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.

Elyxyb - Celecoxib is eLYXYB is indicated for the acute treatment of migraine with or without aura in adults. Marketed by Biodelivery Sciences International Inc, this product is identified by NDC 59385-055 and is authorized under FDA application NDA212157.

Identification & Billing

NDC Package Code
59385-055-22
Package Description
1 BOTTLE in 1 CARTON / 4.8 mL in 1 BOTTLE (59385-055-02)
Product Code
59385-055
11-Digit Billing Format
59385005522
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Elyxyb - Celecoxib
Dosage Form
-
Usage Information
ELYXYB is indicated for the acute treatment of migraine with or without aura in adults.

Regulatory & Marketing

Labeler Name
Biodelivery Sciences International Inc
FDA Application #
NDA212157
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-01-2022
Listing Expiration
12-31-2024
Exclude Flag
I
Sample Package
Yes

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 (59385-055). Click a package code to view its specific billing and regulatory data.

59385-055-06
6 BOTTLE in 1 CARTON / 4.8 mL in 1 BOTTLE (59385-055-01)

* 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 59385-055-22 identifies a specific commercial package of 1 bottle in 1 carton / 4.8 ml in 1 bottle (59385-055-02) of Elyxyb - Celecoxib, labeled by Biodelivery Sciences International Inc. 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 Biodelivery Sciences International Inc on January 01, 2022. The current certification is valid through December 31, 2024.

How is this Biodelivery Sciences International Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59385005522. 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)
59385-055-22
11-Digit CMS (5-4-2)
59385-0055-22

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