Active ingredient
Oxybate
10 finished FDA listings contain Oxybate as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CALCIUM OXYBATE, MAGNESIUM OXYBATE, POTASSIUM OXYBATE, SODIUM OXYBATE
- Dosage forms
- For Suspension, Extended Release, Solution
- Routes
- Oral
- Manufacturers / labelers
- 6
- Strengths listed
- .5 g/ml · 4.5 g/1 · 500 mg/ml · 6 g/1 · 7.5 g/1 · 9 g/1
- Brand names in FDA listings
- Lumryz, Xyrem
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2387302
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021196 | JAZZ PHARMS | 2002-07-17 | 2 |
| NDA 214755 | ALKERMES INC | 2023-05-01 | 4 |
| ANDA 203631 | AMNEAL | 2025-09-10 | 1 |
| ANDA 210523 | ASCENT PHARMS INC | 2025-11-05 | 2 |
Official labeling on DailyMed
- SODIUM OXYBATE SOLUTION [CAMBER PHARMACEUTICALS, INC.] · version 3 · 2026-06-03
- SODIUM OXYBATE SOLUTION [AMNEAL PHARMACEUTICALS LLC] · version 19 · 2026-03-02
- SODIUM OXYBATE SOLUTION [XLCARE PHARMACEUTICALS, INC.] · version 2 · 2026-01-08
- XYREM (SODIUM OXYBATE) SOLUTION [JAZZ PHARMACEUTICALS, INC.] · version 27 · 2025-07-03
- SODIUM OXYBATE SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 5 · 2024-08-19
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.