Quick answers
- What is Sodium oxybate used for?
- The FDA-approved label (Xyrem, Jazz Pharmaceuticals, Inc., July 1, 2025) says: “Xyrem is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. Xyrem is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sodium oxybate have a boxed warning?
- Yes. The FDA label for Xyrem has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Sodium oxybate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sodium oxybate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Sodium oxybate?
- 6 companies list prescription products of Sodium oxybate in the FDA NDC Directory, including Alkermes, Inc., Jazz Pharmaceuticals, Inc. and Amneal Pharmaceuticals LLC.
What Sodium oxybate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Xyrem is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. Xyrem is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
— FDA label: Xyrem, Jazz Pharmaceuticals, Inc., effective July 1, 2025. Read the full label on DailyMed →
The FDA has 5 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
5 of 5 FDA labels for this medicine have a boxed warning.
Forms and how it is given
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Alkermes, Inc.4 products
- Jazz Pharmaceuticals, Inc.1 product
- Amneal Pharmaceuticals LLC1 product
- Hikma Pharmaceuticals USA Inc.1 product
- XLCare Pharmaceuticals, Inc.1 product
- Camber Pharmaceuticals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021196 XYREM | Jazz Pharms | July 17, 2002 | 32, latest July 28, 2025 2025: REMS · 2025: REMS · 2024: REMS |
| NDA214755 LUMRYZ | Alkermes Inc | May 1, 2023 | 6, latest November 10, 2025 2025: Labeling · 2025: REMS · 2024: REMS |
Generic approvals (2)
- ANDA203631Amneal · September 10, 2025
- ANDA210523Ascent Pharms Inc · November 5, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 349482, 352257 |
|---|---|
| SPL set ID of the quoted label | 926eb076-a4a8-45e4-91ef-411f0aa4f3ca |
| FDA labels (SPL) | 5 |
| FDA applications | NDA021196, NDA214755, 2 ANDA |
| Active ingredients (FDA) | SODIUM OXYBATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Xyrem, Jazz Pharmaceuticals, Inc., effective July 1, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →