Xyrem
These highlights do not include all the information needed to use XYREM safely and effectively. See full prescribing information for XYREM. XYREM (sodium oxybate) oral solution, CIIIInitial U.S. Approval: 2002
Approved
Approval ID
926eb076-a4a8-45e4-91ef-411f0aa4f3ca
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 25, 2023
Manufacturers
FDA
Jazz Pharmaceuticals, Inc.
DUNS: 135926363
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sodium oxybate
PRODUCT DETAILS
NDC Product Code68727-100
Application NumberNDA021196
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateApril 28, 2017
Generic Namesodium oxybate
INGREDIENTS (1)
SODIUM OXYBATEActive
Quantity: 0.5 g in 1 mL
Code: 7G33012534
Classification: ACTIB