Lumryz For Suspension, Extended Release
NDC Package 13551-003-07

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

Lumryz (sodium oxybate) for suspensions is a medication used to treat narcolepsy, a condition that causes severe daytime sleepiness. This formulation utilizes a for suspension, extended release delivery system. Marketed by Avadel Cns Pharmaceuticals, Llc, this product is identified by NDC 13551-003 and is authorized under FDA application NDA214755.

Identification & Billing

NDC Package Code
13551-003-07
Package Description
7 PACKET in 1 CARTON / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET
Product Code
13551-003
11-Digit Billing Format
13551000307
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
7 EA
RxNorm Crosswalk
  • RxCUI: 2636822 - sodium oxybate 4.5 GM Granules for extended release Oral Suspension
  • RxCUI: 2636822 - sodium oxybate 4500 MG Granules for Oral Suspension
  • RxCUI: 2636822 - sodium oxybate 4.5 GM (equivalent to 3.7 GM oxybate) Granules for Oral Suspension
  • RxCUI: 2636828 - Lumryz 4.5 GM Granules for extended release Oral Suspension
  • RxCUI: 2636828 - sodium oxybate 4500 MG Granules for Oral Suspension [Lumryz]

Clinical Specifications

Proprietary Name
Lumryz
Non-Proprietary Name
Sodium Oxybate
Substance Name
Sodium Oxybate
Dosage Form
For Suspension, Extended Release - A product, usually a solid, intended for suspension prior to administration; once the suspension is administered, the drug will be released at a constant rate over a specified period.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SODIUM OXYBATE 7.5 g/1
Pharmacologic Class
Usage Information
This medication is used to treat narcolepsy, a condition that causes severe daytime sleepiness. Sodium oxybate can decrease daytime sleepiness and also reduce the number of sudden short attacks of weak/paralyzed muscles (known as cataplexy) that can occur in patients with narcolepsy. Sodium oxybate is a central nervous system depressant. It is also known as gamma hydroxybutyrate (GHB).
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Avadel Cns Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA214755
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-01-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (13551-003). Click a package code to view its specific billing and regulatory data.

13551-003-30
30 PACKET in 1 CARTON / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET

* 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 13551-003-07 identifies a specific commercial package of 7 packet in 1 carton / 1 for suspension, extended release in 1 packet of Lumryz, a human prescription drug labeled by Avadel Cns Pharmaceuticals, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 7 billable units per package. This for suspension, extended release is formulated for oral use and contains sodium oxybate 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 Avadel Cns Pharmaceuticals, Llc on May 01, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat narcolepsy, a condition that causes severe daytime sleepiness. Sodium oxybate can decrease daytime sleepiness and also reduce the number of sudden short attacks of weak/paralyzed muscles (known as cataplexy) that can occur in patients with narcolepsy. Sodium oxybate is a central nervous system depressant. It is also known as gamma hydroxybutyrate (GHB).

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13551000307. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 7 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)
13551-003-07
11-Digit CMS (5-4-2)
13551-0003-07

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