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  4. NDC Product Code: 13551-005 Lumryz

NDC 13551-005 Lumryz

Sodium Oxybate Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 13551-005?
  4. Lumryz Uses
  5. NDC to RxNorm Crosswalk

Product Information

Get all the details for National Drug Code (NDC) 13551-005 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
13551-005
Proprietary Name:
Lumryz
Non-Proprietary Name: [1]
Sodium Oxybate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Avadel Cns Pharmaceuticals, Llc
Labeler Code:
13551
Product Label ID:
10e5e40c-52f3-4c73-8a34-2c29c690a934
FDA Application Number: [6]
NDA214755
DEA Schedule: [7]
Schedule III (CIII) Substances
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
10-07-2024
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
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Product Details

What is NDC 13551-005?

The NDC code 13551-005 is assigned by the FDA to the product Lumryz which is a human prescription drug product labeled by Avadel Cns Pharmaceuticals, Llc. The generic name of Lumryz is sodium oxybate. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 13551-005-01 1 kit in 1 carton * 1 for suspension, extended release in 1 packet * 1 for suspension, extended release in 1 packet * 1 for suspension, extended release in 1 packet. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Lumryz?

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).

What is the NDC to RxNorm Crosswalk for Lumryz?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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]

* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[7] What is the Drug Enforcement Administration (DEA) CIII Schedule? - This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".