FDA.reportPublic FDA data

XYWAV

Product NDC
68727-150
11-digit product format
687270150
Labeler code
68727
Product ID
68727-150_6815ce2b-51e5-4d03-92a6-523718ab0d8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
calcium, magnesium, potassium, and sodium oxybates
Dosage form
SOLUTION
Route
ORAL
Labeler
Jazz Pharmaceuticals, Inc.
Application
NDA212690
Marketing category
NDA
Marketing start
2020-11-02
Substance
CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE
Active strength
.5; .5; .5; .5 g/mL; g/mL; g/mL; g/mL
Pharmacologic classes
Central Nervous System Depressant [EPC], Central Nervous System Depressant [EPC], Central Nervous System Depressant [EPC], Central Nervous System Depressant [EPC], Central Nervous System Depression [PE], Central Nervous System Depression [PE], Central Nervous System Depression [PE], Central Nervous System Depression [PE], Decreased Central Nervous System Organized Electrical Activity [PE], Decreased Central Nervous System Organized Electrical Activity [PE], Decreased Central Nervous System Organized Electrical Activity [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
XYWAV
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM OXYBATE.5 g/mL
MAGNESIUM OXYBATE.5 g/mL
POTASSIUM OXYBATE.5 g/mL
SODIUM OXYBATE.5 g/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8W24SYD6ZI, G983HLV265, S8NKF3H3KT, 7G33012534
Rxcui2393794, 2393795

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
68727-150-01XYWAV180 mL in 1 BOTTLE, PLASTICSOLUTION18016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68727-150XYWAV (CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES) SOLUTION [JAZZ PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 1 package rows20241010_1e0ae43a-037f-42af-8e23-a0e51d75abe8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2393795calcium / magnesium / potassium / sodium oxybates 0.5 GM in 1 mL Oral SolutionPSN1e0ae43a-037f-42af-8e23-a0e51d75abe816
2393794xywav 0.5 GM in 1 mL Oral SolutionPSN1e0ae43a-037f-42af-8e23-a0e51d75abe816
2393794calcium oxybate 234 MG/ML / magnesium oxybate 96 MG/ML / potassium oxybate 130 MG/ML / sodium oxybate 40 MG/ML Oral Solution [Xywav]SBD1e0ae43a-037f-42af-8e23-a0e51d75abe816
2393795calcium oxybate 234 MG/ML / magnesium oxybate 96 MG/ML / potassium oxybate 130 MG/ML / sodium oxybate 40 MG/ML Oral SolutionSCD1e0ae43a-037f-42af-8e23-a0e51d75abe816
2393795calcium oxybate 0.234 GM / magnesium oxybate 0.096 GM / potassium oxybate 0.13 GM / sodium oxybate 0.04 GM per 1 ML Oral SolutionSY1e0ae43a-037f-42af-8e23-a0e51d75abe816
2393795calcium oxybate 234 MG/ML / magnesium oxybate 96 MG/ML / K+ oxybate 130 MG/ML / sodium oxybate 40 MG/ML Oral SolutionSY1e0ae43a-037f-42af-8e23-a0e51d75abe816
2393794calcium oxybate 234 MG/ML / magnesium oxybate 96 MG/ML / K+ oxybate 130 MG/ML / sodium oxybate 40 MG/ML Oral Solution [Xywav]SY1e0ae43a-037f-42af-8e23-a0e51d75abe816
2393795calcium oxybate 234 MG/ML / magnesium oxybate 96 MG/ML / Pot oxybate 130 MG/ML / sodium oxybate 40 MG/ML Oral SolutionSY1e0ae43a-037f-42af-8e23-a0e51d75abe816
2393794calcium oxybate 234 MG/ML / magnesium oxybate 96 MG/ML / Pot oxybate 130 MG/ML / sodium oxybate 40 MG/ML Oral Solution [Xywav]SY1e0ae43a-037f-42af-8e23-a0e51d75abe816
2393795calcium/magnesium/potassium/sodium oxybates 0.5 GM per 1 ML Oral SolutionSY1e0ae43a-037f-42af-8e23-a0e51d75abe816
2393794Xywav (calcium oxybate 0.234 GM / magnesium oxybate 0.096 GM / potassium oxybate 0.13 GM / sodium oxybate 0.04 GM) per 1 ML Oral SolutionSY1e0ae43a-037f-42af-8e23-a0e51d75abe816
2393794Xywav 0.5 GM per 1 ML Oral SolutionSY1e0ae43a-037f-42af-8e23-a0e51d75abe816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68727-150-0168727015001180 mL in 1 BOTTLE, PLASTIC (68727-150-01) 180 ml2020-11-020000-00-00NoNoCurrent