Prescription drug · NDA
Xywav NDC 68727-150
calcium, magnesium, potassium, and sodium oxybates · Sodium oxybate .5 g/mL + 3 more ingredients · Solution · Oral · Jazz Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68727-150-01 | 6872701500168727015001 | 180 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
N468727015001followed by a unit qualifier and the quantityPackage 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.
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.