NDC 68727-100

Xyrem

Sodium Oxybate

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.

• Product ID: 68727-100_39820038-ac66-4e6a-8386-3ba1efb64ceb
• NDC: 68727-100
• Product Type: Human Prescription Drug
• Proprietary Name: Xyrem
• Generic Name: Sodium Oxybate
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2002-07-17
• Marketing Category: NDA / NDA
• Application Number: NDA021196
• Labeler Name: Jazz Pharmaceuticals, Inc.
• Substance Name: SODIUM OXYBATE
• Active Ingredient Strength: 1 g/mL
• Pharm Classes: Central Nervous System Depressant [EPC],Central Nervous System Depression [PE],Decreased Central Nervous System Organized Electrical Activity [PE]
• DEA Schedule: CIII
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 68727-100-01

180 mL in 1 BOTTLE, PLASTIC (68727-100-01)

• Marketing Start Date: 2002-07-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68727-100-01 [68727010001]

Xyrem SOLUTION

• Marketing Category: NDA
• Application Number: NDA021196
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2002-07-17

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM OXYBATE	.5 g/mL

OpenFDA Data

• SPL SET ID: 926eb076-a4a8-45e4-91ef-411f0aa4f3ca
• Manufacturer:
  • Jazz Pharmaceuticals, Inc.
• UNII:
  • 7G33012534
• RxNorm Concept Unique ID - RxCUI:
  • 349482
  • 352257

Pharmacological Class

• Central Nervous System Depressant [EPC]
• Central Nervous System Depression [PE]
• Decreased Central Nervous System Organized Electrical Activity [PE]
• Central Nervous System Depressant [EPC]
• Central Nervous System Depression [PE]
• Decreased Central Nervous System Organized Electrical Activity [PE]

NDC Crossover Matching brand name "Xyrem" or generic name "Sodium Oxybate"

NDC	Brand Name	Generic Name
68727-100	Xyrem	sodium oxybate
0054-9628	N/A	sodium oxybate