Search by Drug Name or NDC
NDC 68727-0100-01 Xyrem 0.5 g/mL Details
Xyrem 0.5 g/mL
Xyrem is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Jazz Pharmaceuticals, Inc.. The primary component is SODIUM OXYBATE.
MedlinePlus Drug Summary
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.
Related Packages: 68727-0100-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Calcium, Magnesium, Potassium, and 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.
Related Packages: 68727-0100-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Sodium Oxybate
Product Information
| NDC | 68727-0100 |
|---|---|
| Product ID | 68727-100_c0195565-56b4-426a-8b1a-868519d6dfaa |
| Associated GPIs | 62450060202020 |
| GCN Sequence Number | 050813 |
| GCN Sequence Number Description | sodium oxybate SOLUTION 500 MG/ML ORAL |
| HIC3 | H7W |
| HIC3 Description | ANTI-NARCOLEPSY,ANTI-CATAPLEXY,SEDATIVE-TYPE AGENT |
| GCN | 18104 |
| HICL Sequence Number | 012346 |
| HICL Sequence Number Description | SODIUM OXYBATE |
| Brand/Generic | Brand |
| Proprietary Name | Xyrem |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | sodium oxybate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 0.5 |
| Active Ingredient Units | g/mL |
| Substance Name | SODIUM OXYBATE |
| Labeler Name | Jazz Pharmaceuticals, Inc. |
| Pharmaceutical Class | Central Nervous System Depressant [EPC], Central Nervous System Depression [PE], Decreased Central Nervous System Organized Electrical Activity [PE] |
| DEA Schedule | CIII |
| Marketing Category | NDA |
| Application Number | NDA021196 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68727-0100-01 (68727010001)
| NDC Package Code | 68727-100-01 |
|---|---|
| Billing NDC | 68727010001 |
| Package | 180 mL in 1 BOTTLE, PLASTIC (68727-100-01) |
| Marketing Start Date | 2002-07-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |