NDC codes

FDA NDC Directory
Product NDC (as listed)68727-150Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68727-0150Add 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 NDC11-digit (billing)PackageCopy
68727-150-016872701500168727015001180 mL in 1 BOTTLE, PLASTIC (68727-150-01)Marketed from Nov 2, 2020

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)
Xywav
Generic name (nonproprietary)
calcium, magnesium, potassium, and sodium oxybates
Active ingredients
Sodium oxybate — .5 g/mLCalcium oxybate — .5 g/mLPotassium oxybate — .5 g/mLMagnesium 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 212690
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Central Nervous System Depression (Physiologic effect)Central Nervous System Depression (Physiologic effect)Central Nervous System Depression (Physiologic effect)Central Nervous System Depression (Physiologic effect)Decreased Central Nervous System Organized Electrical Activity (Physiologic effect)Decreased Central Nervous System Organized Electrical Activity (Physiologic effect)Decreased Central Nervous System Organized Electrical Activity (Physiologic effect)Decreased Central Nervous System Organized Electrical Activity (Physiologic effect)
Identifiers
Product ID 68727-150_6815ce2b-51e5-4d03-92a6-523718ab0d8cSPL ID 6815ce2b-51e5-4d03-92a6-523718ab0d8cSPL set ID 1e0ae43a-037f-42af-8e23-a0e51d75abe8RxCUI 2393794, 2393795UNII 7G33012534, 8W24SYD6ZI, S8NKF3H3KT, G983HLV265
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

N468727015001 followed by a unit qualifier and the quantity

Package 68727-0150-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

XYWAV 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 ( 1.1 ). • Idiopathic Hypersomnia (IH) in adults ( 1.2 ). 1.1 Narcolepsy XYWAV is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. 1.2 Idiopathic Hypersomnia XYWAV is indicated for the treatment of idiopathic hypersomnia (IH) in adults.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68727-150

What is NDC 68727-150?
68727-150 is the product NDC for Xywav, Sodium oxybate .5 g/mL + 3 more ingredients 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?
Xywav (Calcium, magnesium, potassium, and sodium oxybates).
What is the active ingredient?
Sodium oxybate, Calcium oxybate, Potassium oxybate, Magnesium 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 Xywav?
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.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in