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Lumryz

These highlights do not include all the information needed to use LUMRYZ™ safely and effectively. See full prescribing information for LUMRYZ. LUMRYZ (sodium oxybate) for extended-release oral suspension, CIIIInitial U.S. Approval: 2002

Approved
Approval ID

10e5e40c-52f3-4c73-8a34-2c29c690a934

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 7, 2023

Manufacturers
FDA

Avadel CNS Pharmaceuticals, LLC

DUNS: 117441358

Products 4

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 Code13551-002
Application NumberNDA214755
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium oxybate
Product Specifications
Route of AdministrationORAL
Effective DateMay 17, 2023
FDA Product Classification

INGREDIENTS (1)

SODIUM OXYBATEActive
Quantity: 6 g in 1 1
Code: 7G33012534
Classification: ACTIB

sodium oxybate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code13551-001
Application NumberNDA214755
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium oxybate
Product Specifications
Route of AdministrationORAL
Effective DateMay 17, 2023
FDA Product Classification

INGREDIENTS (1)

SODIUM OXYBATEActive
Quantity: 4.5 g in 1 1
Code: 7G33012534
Classification: ACTIB

sodium oxybate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code13551-003
Application NumberNDA214755
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium oxybate
Product Specifications
Route of AdministrationORAL
Effective DateMay 17, 2023
FDA Product Classification

INGREDIENTS (1)

SODIUM OXYBATEActive
Quantity: 7.5 g in 1 1
Code: 7G33012534
Classification: ACTIB

sodium oxybate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code13551-004
Application NumberNDA214755
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium oxybate
Product Specifications
Route of AdministrationORAL
Effective DateMay 17, 2023
FDA Product Classification

INGREDIENTS (1)

SODIUM OXYBATEActive
Quantity: 9 g in 1 1
Code: 7G33012534
Classification: ACTIB

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Lumryz - FDA Drug Approval Details