Drug
Who makes sodium oxybate?
6 companies list sodium oxybate as a human prescription drug, including under the names Lumryz, Xyrem. Forms: for suspension, extended release; kit; solution. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing sodium oxybate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Alkermes, Inc.United States | for suspension, extended release; kit | NDANDA214755 | 5 | 2 |
| Hikma Pharmaceuticals USA Inc.United States | solution | NDA AUTHORIZED GENERICNDA021196 | 1 | 4 |
| Jazz Pharmaceuticals Operations UK LimitedIreland | solution | NDANDA021196 | 1 | 3 |
| Amneal Ireland LimitedIreland | solution | ANDAANDA203631 | 1 | 1 |
| Camber Pharmaceuticals, Inc.United States | solution | ANDAANDA210523 | 1 | 1 |
| XLCare Pharmaceuticals Inc.United States | solution | ANDAANDA210523 | 1 | 1 |
Bulk ingredient listings
- Cambrex Charles City, Inc. · 1 NDC
- Chattem Chemicals, Inc.United States · 1 NDC
- Siegfried USA, LLCUnited States · 1 NDC
- Veranova, L.P.United States · 1 NDC
Orange Book patents
42 unexpired patents list sodium oxybate as the active ingredient, expiring between Mar 2033 and Mar 2042. Application holders: ALKERMES INC, JAZZ PHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes sodium oxybate?
- 6 companies list sodium oxybate as a human prescription drug in the openFDA NDC Directory, led by Alkermes, Inc., Hikma Pharmaceuticals USA Inc., Jazz Pharmaceuticals Operations UK Limited, Amneal Ireland Limited, Camber Pharmaceuticals, Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Lumryz?
- 3 companies list sodium oxybate under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies sodium oxybate active ingredient?
- 4 companies list sodium oxybate as a bulk ingredient, including Cambrex Charles City, Inc., Chattem Chemicals, Inc., Siegfried USA, LLC, Veranova, L.P..