NDC 68727-100 Xyrem
Sodium Oxybate Solution Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Code Structure Chart
Product Details
What is NDC 68727-100?
What are the uses for Xyrem?
What are Xyrem Active Ingredients?
- SODIUM OXYBATE .5 g/mL - The sodium salt of 4-hydroxybutyric acid. It is used for both induction and maintenance of ANESTHESIA.
Which are Xyrem UNII Codes?
The UNII codes for the active ingredients in this product are:
- SODIUM OXYBATE (UNII: 7G33012534)
- 4-HYDROXYBUTANOIC ACID (UNII: 30IW36W5B2) (Active Moiety)
What is the NDC to RxNorm Crosswalk for Xyrem?
- RxCUI: 349482 - sodium oxybate 500 MG in 1 mL Oral Solution
- RxCUI: 349482 - sodium oxybate 500 MG/ML Oral Solution
- RxCUI: 349482 - sodium oxybate 500 MG per 1 ML Oral Solution
- RxCUI: 352257 - XYREM 0.5 GM in 1 mL Oral Solution
- RxCUI: 352257 - sodium oxybate 500 MG/ML Oral Solution [Xyrem]
Which are the Pharmacologic Classes for Xyrem?
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Patient Education
Calcium, Magnesium, Potassium, and Sodium Oxybate
Calcium, magnesium, potassium, and sodium oxybate is used to treat attacks of cataplexy (episodes of muscle weakness that begin suddenly and last for a short time) and excessive daytime sleepiness in adults and children 7 years of age and older who have narcolepsy (a sleep disorder that may cause extreme sleepiness, sudden uncontrollable urge to sleep during daily activities, and cataplexy). Calcium, magnesium, potassium, and sodium oxybate is also used to treat adults who have idiopathic hypersomnia (IH; a sleep disorder that may cause excessive daytime sleepiness and uncontrollable urge to sleep during daily activities despite adequate or prolonged nighttime sleep). Calcium, magnesium, potassium, and sodium oxybate is in a class of medications called central nervous system depressants. Calcium, magnesium, potassium, and sodium oxybate works to treat narcolepsy, cataplexy, and idiopathic hypersomnia by reducing activity in the brain.
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Sodium Oxybate
Sodium oxybate is used to prevent attacks of cataplexy (episodes of muscle weakness that begin suddenly and last for a short time) and excessive daytime sleepiness in adults and children 7 years of age and older who have narcolepsy (a sleep disorder that may cause extreme sleepiness, sudden uncontrollable urge to sleep during daily activities, and cataplexy). Sodium oxybate is in a class of medications called central nervous system depressants. Sodium oxybate works to treat narcolepsy and cataplexy by reducing activity in the brain.
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* Please review the disclaimer below.
[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.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[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 ("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".