What is NDC 68727-100?

68727-100 is the product NDC for Xyrem (sodium oxybate), Sodium oxybate .5 g/mL solution, listed with the FDA by Jazz Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Jazz Pharmaceuticals, Inc., NDC labeler code 68727. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Xyrem?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Xyrem NDC 68727-100 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68727-100Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68727-0100Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
68727-100-01	6872701000168727010001	180 mL in 1 BOTTLE, PLASTIC (68727-100-01)Marketed from Jul 17, 2002

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Xyrem
Generic name (nonproprietary): sodium oxybate
Active ingredients: Sodium oxybate — .5 g/mL
Dosage form: Solution
Route: Oral
Labeler: Jazz Pharmaceuticals, Inc.NDC labeler code 68727
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021196
Marketing start: Jul 17, 2002
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Central Nervous System Depression (Physiologic effect)Decreased Central Nervous System Organized Electrical Activity (Physiologic effect)
Identifiers: Product ID 68727-100_3839d447-e97d-496d-8e9d-aaef53f1484fSPL ID 3839d447-e97d-496d-8e9d-aaef53f1484fSPL set ID 926eb076-a4a8-45e4-91ef-411f0aa4f3caRxCUI 349482, 352257UNII 7G33012534
Pharmacologic class: Central Nervous System Depressant

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N468727010001 followed by a unit qualifier and the quantity

Package 68727-0100-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jul 1, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Xyrem is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. Xyrem is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68727-100

What is NDC 68727-100?: 68727-100 is the product NDC for Xyrem (sodium oxybate), Sodium oxybate .5 g/mL solution, listed with the FDA by Jazz Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Xyrem (Sodium oxybate).
What is the active ingredient?: Sodium oxybate.
Who is the labeler?: Jazz Pharmaceuticals, Inc., NDC labeler code 68727. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Xyrem?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 021196

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021196
Product	Strength	Form · route	Labeler	Product NDC
sodium oxybate	Sodium oxybate .5 g/mL	SolutionOral	Hikma Pharmaceuticals USA Inc.	0054-9628

Xyrem (Sodium oxybate) NDC 68727-100