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
a6c17f6f-46bc-4852-a825-07f49cc08495
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 25, 2023
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
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 Code69238-2391
Application NumberNDA021196
Product Classification
M
Marketing Category
C73605
G
Generic Name
sodium oxybate
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2023
FDA Product Classification
INGREDIENTS (1)
SODIUM OXYBATEActive
Quantity: .5 g in 1 mL
Code: 7G33012534
Classification: ACTIB