DEA schedule
Is sodium oxybate a controlled substance?
Federal schedule for sodium oxybate from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
Yes. Sodium 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 | 9 prescription listings from 6 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 |
Sodium Oxybate NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 13551-001 | Lumryz | for suspension, extended release | 4.5 g/1 | Alkermes, Inc. | CIII |
| 13551-002 | Lumryz | for suspension, extended release | 6 g/1 | Alkermes, Inc. | CIII |
| 13551-003 | Lumryz | for suspension, extended release | 7.5 g/1 | Alkermes, Inc. | CIII |
| 13551-004 | Lumryz | for suspension, extended release | 9 g/1 | Alkermes, Inc. | CIII |
| 68727-100 | Xyrem | solution | .5 g/mL | Jazz Pharmaceuticals, Inc. | CIII |
| 0054-9628 | sodium oxybate | solution | .5 g/mL | Hikma Pharmaceuticals USA Inc. | CIII |
| 31722-891 | sodium oxybate | solution | .5 g/mL | Camber Pharmaceuticals, Inc. | CIII |
| 72865-349 | sodium oxybate | solution | .5 g/mL | XLCare Pharmaceuticals, Inc. | CIII |
| 65162-065 | Sodium Oxybate | solution | 500 mg/mL | Amneal Pharmaceuticals LLC | CIII |
Questions
Is sodium oxybate a controlled substance?
Yes. Sodium oxybate is a Schedule III controlled substance under the federal Controlled Substances Act. Matching DEA list entry: Gamma Hydroxybutyric Acid preparations (Schedule III).
Is sodium oxybate a narcotic?
No. The DEA list does not mark sodium 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 sodium oxybate?
Sodium oxybate 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 Sodium Oxybate
- What is Sodium Oxybate used for?FDA label uses
- Generic for LumryzFDA Orange Book
- Generic for XyremFDA Orange Book
- What is Xyrem used for?FDA label uses
- Is Xyrem a controlled substance?Schedule III
- What is Lumryz used for?FDA label uses
- Is Lumryz a controlled substance?Schedule III
- Central Nervous System Depressants listFDA drug class
- NDC 13551-001Sodium Oxybate NDC record
- NDC 13551-002Sodium Oxybate NDC record
- NDC 13551-003Sodium Oxybate NDC record
- Schedule III drugs listDEA schedule