XYWAV
These highlights do not include all the information needed to use XYWAV safely and effectively. See full prescribing information for XYWAV. XYWAV (calcium, magnesium, potassium, and sodium oxybates) oral solution, CIIIInitial U.S. Approval: 2002
Approved
Approval ID
1e0ae43a-037f-42af-8e23-a0e51d75abe8
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.
(calcium, magnesium, potassium, and sodium oxybates)
PRODUCT DETAILS
NDC Product Code68727-150
Application NumberNDA212690
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateMarch 10, 2022
Generic Name(calcium, magnesium, potassium, and sodium oxybates)
INGREDIENTS (4)
SODIUM OXYBATEActive
Quantity: 0.5 g in 1 mL
Code: 7G33012534
Classification: ACTIB
Calcium OxybateActive
Quantity: 0.5 g in 1 mL
Code: 8W24SYD6ZI
Classification: ACTIB
Potassium OxybateActive
Quantity: 0.5 g in 1 mL
Code: S8NKF3H3KT
Classification: ACTIB
Magnesium OxybateActive
Quantity: 0.5 g in 1 mL
Code: G983HLV265
Classification: ACTIB