Nouress
NDC Package 76014-006-05

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

Package Information

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

Nouress is indicated for use as an additive to amino acids solutions to meet nutritional requirements of neonates (preterm and term infants less than one month of age) requiring total parenteral nutrition. Marketed by Avadel Legacy Pharmaceuticals, Llc, this product is identified by NDC 76014-006 and is authorized under FDA application NDA212535.

Identification & Billing

NDC Package Code
76014-006-05
Package Description
5 VIAL, SINGLE-USE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-USE (76014-006-33)
Product Code
76014-006
11-Digit Billing Format
76014000605
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nouress
Dosage Form
-
Usage Information
NOURESS is indicated for use as an additive to amino acids solutions to meet nutritional requirements of neonates (preterm and term infants less than one month of age) requiring total parenteral nutrition.

Regulatory & Marketing

Labeler Name
Avadel Legacy Pharmaceuticals, Llc
FDA Application #
NDA212535
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-01-2020
Listing Expiration
12-31-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 76014-006-05 identifies a specific commercial package of 5 vial, single-use in 1 carton / 10 ml in 1 vial, single-use (76014-006-33) of Nouress, labeled by Avadel Legacy Pharmaceuticals, Llc. 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 Avadel Legacy Pharmaceuticals, Llc on April 01, 2020. The current certification is valid through December 31, 2021.

How is this Avadel Legacy Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76014000605. 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)
76014-006-05
11-Digit CMS (5-4-2)
76014-0006-05

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