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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-9628
Application NumberNDA021196
Product Classification
M
Marketing Category
C73605
G
Generic Name
sodium oxybate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2022
FDA Product Classification
INGREDIENTS (1)
SODIUM OXYBATEActive
Quantity: .5 g in 1 mL
Code: 7G33012534
Classification: ACTIB