DEA schedule
Is Xywav a controlled substance?
Xywav contains sodium oxybate, calcium oxybate, potassium oxybate and magnesium oxybate. Federal schedule from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
Yes. Xywav (sodium oxybate, calcium oxybate, potassium oxybate and magnesium oxybate) is a Schedule III controlled substance under the federal Controlled Substances Act. Matching DEA list entry: Gamma Hydroxybutyric Acid preparations (Schedule III).
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 1 prescription listings from 1 labelers, all Schedule III |
| DEA controlled substances list | Gamma Hydroxybutyric Acid: Schedule I; Gamma Hydroxybutyric Acid preparations: Schedule III |
DEA list entry
| Substance | DEA code | Schedule | Narcotic | Other names | Match |
|---|---|---|---|---|---|
| Gamma Hydroxybutyric Acid | 2010 | I | No | GHB; gamma hydroxybutyrate; sodium oxybate | Isomer or salt of the listed substance (21 CFR 1308) |
| Gamma Hydroxybutyric Acid preparations | 2012 | III | No | Xyrem | Listed combination or preparation |
| Gamma Hydroxybutyric Acid | 2010 | I | No | GHB; gamma hydroxybutyrate; sodium oxybate | Isomer or salt of the listed substance (21 CFR 1308) |
| Gamma Hydroxybutyric Acid preparations | 2012 | III | No | Xyrem | Listed combination or preparation |
| Gamma Hydroxybutyric Acid | 2010 | I | No | GHB; gamma hydroxybutyrate; sodium oxybate | Isomer or salt of the listed substance (21 CFR 1308) |
| Gamma Hydroxybutyric Acid preparations | 2012 | III | No | Xyrem | Listed combination or preparation |
| Gamma Hydroxybutyric Acid | 2010 | I | No | GHB; gamma hydroxybutyrate; sodium oxybate | Isomer or salt of the listed substance (21 CFR 1308) |
| Gamma Hydroxybutyric Acid preparations | 2012 | III | No | Xyrem | Listed combination or preparation |
Xywav NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 68727-150 | XYWAV | solution | .5 g/mL; .5 g/mL; .5 g/mL; .5 g/mL | Jazz Pharmaceuticals, Inc. | CIII |
Questions
Is Xywav a controlled substance?
Yes. Xywav (sodium oxybate, calcium oxybate, potassium oxybate and magnesium oxybate) is a Schedule III controlled substance under the federal Controlled Substances Act. Matching DEA list entry: Gamma Hydroxybutyric Acid preparations (Schedule III).
Is Xywav a narcotic?
No. The DEA list does not mark sodium oxybate, calcium oxybate, potassium oxybate and magnesium oxybate as a narcotic (NARC = N) and places it in Schedule III. Its FDA established pharmacologic class is Central Nervous System Depressant.
What schedule is Xywav?
Xywav is Schedule III in the FDA NDC directory, which matches the DEA controlled substances list.
Does this page cover state schedules?
No. This page reports the federal schedule only. Some states schedule drugs on their own; check your state board of pharmacy.
More on Xywav
- What is Xywav used for?FDA label uses
- Generic for XywavFDA Orange Book
- Is Sodium Oxybate, Calcium Oxybate, Potassium Oxybate and Magnesium Oxybate a controlled substance?Schedule III
- Central Nervous System Depressants listFDA drug class
- Xywav Medicare Part D coverageBy plan and state
- NDC 68727-150Xywav NDC record
- Schedule III drugs listDEA schedule