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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68727-100
Application NumberNDA021196
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium oxybate
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2017
FDA Product Classification
INGREDIENTS (1)
SODIUM OXYBATEActive
Quantity: 0.5 g in 1 mL
Code: 7G33012534
Classification: ACTIB