FDA.reportPublic FDA data

Lumryz

Product NDC
13551-004
11-digit product format
135510004
Labeler code
13551
Product ID
13551-004_bd9a6c48-be50-44e5-8cbb-87cbaafe936d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium oxybate
Dosage form
FOR SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
Avadel CNS Pharmaceuticals, LLC
Application
NDA214755
Marketing category
NDA
Marketing start
2023-05-01
Substance
SODIUM OXYBATE
Active strength
9 g/1
Pharmacologic classes
Central Nervous System Depressant [EPC], Central Nervous System Depression [PE], Decreased Central Nervous System Organized Electrical Activity [PE]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lumryz
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM OXYBATE9 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7G33012534
Rxcui2636822, 2636828, 2636830, 2636832, 2636834, 2636836, 2636838, 2636840, 2698135, 2698136

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2e88548e-cd6c-4b2e-a954-1bb23670f612Product name120231010
b3e31acf-ce79-4bd9-845e-03c8d973021aProduct name120210203
a3ec038e-96ea-8cce-3e80-6c56853019f6Product name220170424

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13551-004-07Lumryz1 in 1 PACKETFOR SUSPENSION, EXTENDED RELEASE110
13551-004-07Lumryz7 in 1 CARTONFOR SUSPENSION, EXTENDED RELEASE710
13551-004-30Lumryz1 in 1 PACKETFOR SUSPENSION, EXTENDED RELEASE110
13551-004-30Lumryz30 in 1 CARTONFOR SUSPENSION, EXTENDED RELEASE3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13551-004-07EA - Each13551-0042e559fdd-9944-4cc4-8755-10542328051e12023-06-06
13551-004-30EA - Each13551-0043317b418-32f4-47bc-b23c-bd80c835142f12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13551-004LUMRYZ (SODIUM OXYBATE) FOR SUSPENSION, EXTENDED RELEASE LUMRYZ (SODIUM OXYBATE) KIT [AVADEL CNS PHARMACEUTICALS, LLC]8Current NDC, 4 package rows20250416_10e5e40c-52f3-4c73-8a34-2c29c690a934.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2698136{7 (sodium oxybate 4500 MG Granules for Oral Suspension [Lumryz]) / 14 (sodium oxybate 6000 MG Granules for Oral Suspension [Lumryz]) / 7 (sodium oxybate 7500 MG Granules for Oral Suspension [Lumryz]) } Pack [Lumryz 28-Day Starter Pack]BPCK10e5e40c-52f3-4c73-8a34-2c29c690a93410
2698135{7 (sodium oxybate 4500 MG Granules for Oral Suspension) / 14 (sodium oxybate 6000 MG Granules for Oral Suspension) / 7 (sodium oxybate 7500 MG Granules for Oral Suspension) } PackGPCK10e5e40c-52f3-4c73-8a34-2c29c690a93410
2698136Lumryz 28-Day Starter PackPSN10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636828Lumryz 4.5 GM Granules for extended release Oral SuspensionPSN10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636832Lumryz 6 GM Granules for extended release Oral SuspensionPSN10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636836Lumryz 7.5 GM Granules for extended release Oral SuspensionPSN10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636840Lumryz 9 GM Granules for extended release Oral SuspensionPSN10e5e40c-52f3-4c73-8a34-2c29c690a93410
2698135sodium oxybate 28-Day Starter PackPSN10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636822sodium oxybate 4.5 GM Granules for extended release Oral SuspensionPSN10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636830sodium oxybate 6 GM Granules for extended release Oral SuspensionPSN10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636834sodium oxybate 7.5 GM Granules for extended release Oral SuspensionPSN10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636838sodium oxybate 9 GM Granules for extended release Oral SuspensionPSN10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636828sodium oxybate 4500 MG Granules for Oral Suspension [Lumryz]SBD10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636832sodium oxybate 6000 MG Granules for Oral Suspension [Lumryz]SBD10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636836sodium oxybate 7500 MG Granules for Oral Suspension [Lumryz]SBD10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636840sodium oxybate 9000 MG Granules for Oral Suspension [Lumryz]SBD10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636822sodium oxybate 4500 MG Granules for Oral SuspensionSCD10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636830sodium oxybate 6000 MG Granules for Oral SuspensionSCD10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636834sodium oxybate 7500 MG Granules for Oral SuspensionSCD10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636838sodium oxybate 9000 MG Granules for Oral SuspensionSCD10e5e40c-52f3-4c73-8a34-2c29c690a93410
2698136Lumryz 28-Day Starter PackSY10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636828Lumryz 4.5 GM (equivalent to 3.7 GM oxybate) Granules for Oral SuspensionSY10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636828Lumryz 4500 MG Granules for Oral SuspensionSY10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636832Lumryz 6 GM (equivalent to 5 GM oxybate) Granules for Oral SuspensionSY10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636832Lumryz 6000 MG Granules for Oral SuspensionSY10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636836Lumryz 7.5 GM (equivalent to 6.2 GM oxybate) Granules for Oral SuspensionSY10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636836Lumryz 7500 MG Granules for Oral SuspensionSY10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636840Lumryz 9 GM (equivalent to 7.4 GM oxybate) Granules for Oral SuspensionSY10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636840Lumryz 9000 MG Granules for Oral SuspensionSY10e5e40c-52f3-4c73-8a34-2c29c690a93410
2698135sodium oxybate 28-Day Starter PackSY10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636822sodium oxybate 4.5 GM (equivalent to 3.7 GM oxybate) Granules for Oral SuspensionSY10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636830sodium oxybate 6 GM (equivalent to 5 GM oxybate) Granules for Oral SuspensionSY10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636834sodium oxybate 7.5 GM (equivalent to 6.2 GM oxybate) Granules for Oral SuspensionSY10e5e40c-52f3-4c73-8a34-2c29c690a93410
2636838sodium oxybate 9 GM (equivalent to 7.4 GM oxybate) Granules for Oral SuspensionSY10e5e40c-52f3-4c73-8a34-2c29c690a93410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13551-004-07135510004077 PACKET in 1 CARTON (13551-004-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET7 packet2023-05-01NoNoHistorical
13551-004-301355100043030 PACKET in 1 CARTON (13551-004-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET30 packet2023-05-01NoNoHistorical