1. Home
  2. Labeler Index
  3. Recipharm Pessac
  4. NDC Product Code: 82646-006 Sodium Oxybate

NDC 82646-006 Sodium Oxybate

For Suspension, Extended Release - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 82646-006?
  4. Sodium Oxybate Uses
  5. Active Ingredients

Product Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.
NDC Product Code:
82646-006
Proprietary Name:
Sodium Oxybate
Non-Proprietary Name: [1]
Sodium Oxybate
Substance Name: [2]
Sodium Oxybate
NDC Directory Status:
Drug For Further Processing
Product Type: [3]
UNFINISHED PRODUCT INCLUDED in the NDC Directory
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.
Labeler Name: [5]
Recipharm Pessac
Labeler Code:
82646
DEA Schedule: [7]
Schedule III (CIII) Substances
Marketing Category: [8]
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date: [9]
05-01-2023
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
N
Unfinished Product: [13]
Yes
Code Navigator:

Code Structure Chart

Product Details

What is NDC 82646-006?

The NDC code 82646-006 is assigned by the FDA to the UNFINISHED product Sodium Oxybate which is drug for further processing product labeled by Recipharm Pessac. The generic name of Sodium Oxybate is sodium oxybate. The product's dosage form is for suspension, extended release. The product is distributed in a single package with assigned NDC code 82646-006-01 6 carton in 1 box / 80 packet in 1 carton / 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 Sodium Oxybate?

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 are Sodium Oxybate Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • SODIUM OXYBATE 6 g/1 - The sodium salt of 4-hydroxybutyric acid. It is used for both induction and maintenance of ANESTHESIA.

* 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.

[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

[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.

[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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

[13] What is an Unfinished Product? - This field indicates if the product is an unfinished drug. An unfinished drug is an active pharmaceutical ingredient either alone or with other ingredients that is not a finished drug product. Unfinished drugs are used to process other drugs or for drug compounding.