Xyrem

Product NDC: 68727-100
11-digit product format: 687270100
Labeler code: 68727
Product ID: 68727-100_3839d447-e97d-496d-8e9d-aaef53f1484f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sodium oxybate
Dosage form: SOLUTION
Route: ORAL
Labeler: Jazz Pharmaceuticals, Inc.
Application: NDA021196
Marketing category: NDA
Marketing start: 2002-07-17
Substance: SODIUM OXYBATE
Active strength: .5 g/mL
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#

Ingredient, Strength table
Ingredient	Strength
SODIUM OXYBATE	.5 g/mL

Field, Values table
Field	Values
Unii	7G33012534
Rxcui	349482, 352257

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2e88548e-cd6c-4b2e-a954-1bb23670f612	Product name	1	20231010
b3e31acf-ce79-4bd9-845e-03c8d973021a	Product name	1	20210203
a3ec038e-96ea-8cce-3e80-6c56853019f6	Product name	2	20170424

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68727-100-01	Xyrem	180 mL in 1 BOTTLE, PLASTIC	SOLUTION	180		27

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68727-100-01	ML - Milliliter	68727-100	745ee2cd-9e3d-4456-ae28-68fe8b7dfe0d	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
SODIUM OXYBATE	ACTIVE INGREDIENT	7G33012534	XYREM (SODIUM OXYBATE) SOLUTION [JAZZ PHARMACEUTICALS, INC.]	9
4-HYDROXYBUTANOIC ACID	ACTIVE MOIETY	30IW36W5B2	XYREM (SODIUM OXYBATE) SOLUTION [JAZZ PHARMACEUTICALS, INC.]	9

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68727-100	XYREM (SODIUM OXYBATE) SOLUTION [JAZZ PHARMACEUTICALS, INC.]	26	Current NDC, Legacy NDC, 1 package rows	20240817_926eb076-a4a8-45e4-91ef-411f0aa4f3ca.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7G33012534	SODIUM OXYBATE	502-85-2	SODIUM OXYBATE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
349482	sodium oxybate 500 MG in 1 mL Oral Solution	PSN	926eb076-a4a8-45e4-91ef-411f0aa4f3ca	27
352257	XYREM 0.5 GM in 1 mL Oral Solution	PSN	926eb076-a4a8-45e4-91ef-411f0aa4f3ca	27
352257	sodium oxybate 500 MG/ML Oral Solution [Xyrem]	SBD	926eb076-a4a8-45e4-91ef-411f0aa4f3ca	27
349482	sodium oxybate 500 MG/ML Oral Solution	SCD	926eb076-a4a8-45e4-91ef-411f0aa4f3ca	27
349482	sodium oxybate 0.5 GM per 1 ML Oral Solution	SY	926eb076-a4a8-45e4-91ef-411f0aa4f3ca	27
349482	sodium oxybate 500 MG per 1 ML Oral Solution	SY	926eb076-a4a8-45e4-91ef-411f0aa4f3ca	27
352257	Xyrem 0.5 GM per 1 ML Oral Solution	SY	926eb076-a4a8-45e4-91ef-411f0aa4f3ca	27
352257	Xyrem 500 MG per 1 ML Oral Solution	SY	926eb076-a4a8-45e4-91ef-411f0aa4f3ca	27

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68727-100-01	68727010001	180 mL in 1 BOTTLE, PLASTIC (68727-100-01)	180 ml	2002-07-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Xyrem	Jazz Pharmaceuticals, Inc. \| Jazz Pharmaceuticals Ireland Limited	2025-07-01	HUMAN PRESCRIPTION DRUG LABEL	27