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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

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sodium oxybate - FDA Drug Approval Details