sodium oxybate
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2002
Approved
Approval ID
bcef2c95-35e9-464d-9025-652acff769e7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 25, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 080189610
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 Code0054-9628
Application NumberNDA021196
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateOctober 4, 2022
Generic Namesodium oxybate
INGREDIENTS (1)
SODIUM OXYBATEActive
Quantity: .5 g in 1 mL
Code: 7G33012534
Classification: ACTIB