XYWAV is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Jazz Pharmaceuticals, Inc.. The primary component is Sodium Oxybate; Calcium Oxybate; Potassium Oxybate; Magnesium Oxybate.
| Product ID | 68727-150_128ed05a-6bef-4f3e-a6a6-3e88f04aa86c |
| NDC | 68727-150 |
| Product Type | Human Prescription Drug |
| Proprietary Name | XYWAV |
| Generic Name | (calcium, Magnesium, Potassium, And Sodium Oxybates) |
| Dosage Form | Solution |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-11-02 |
| Marketing Category | NDA / NDA |
| Application Number | NDA212690 |
| Labeler Name | Jazz Pharmaceuticals, Inc. |
| Substance Name | SODIUM OXYBATE; CALCIUM OXYBATE; POTASSIUM OXYBATE; MAGNESIUM OXYBATE |
| Active Ingredient Strength | 1 g/mL; g/mL; g/mL; g/mL |
| Pharm Classes | Central Nervous System Depressant [EPC],Central Nervous System Depression [PE],Decreased Central Nervous System Organized Electrical Activity [PE],Central Nervous System Depressant [EPC],Central Nervous System Depression [PE],Decreased Central Nervous System Organized Electrical Activity [PE],Central Nervous System Depressant [EPC],Central Nervous System Depression [PE],Decreased Central Nervous System Organized Electrical Activity [PE],Central Nervous System Depressant [EPC],Central Nervous System Depression [PE],Decreased Central Nervous System Organized Electrical Activity [PE] |
| DEA Schedule | CIII |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2020-11-02 |
| NDC Exclude Flag | N |
| Sample Package? | N |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() XYWAV 88546670 not registered Live/Pending |
Jazz Pharmaceuticals, Inc. 2019-07-29 |