Quick answers
- What is Calcium, magnesium, potassium, and sodium oxybates used for?
- The FDA-approved label (Xywav, Jazz Pharmaceuticals, Inc., July 1, 2025) says: “XYWAV 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. • Idiopathic Hypersomnia (IH) in adults. 1.1 Narcolepsy XYWAV is 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 Calcium, magnesium, potassium, and sodium oxybates have a boxed warning?
- Yes. The FDA label for Xywav has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Calcium, magnesium, potassium, and sodium oxybates?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Calcium, magnesium, potassium, and sodium oxybates been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Calcium, magnesium, potassium, and sodium oxybates?
- 1 company lists prescription products of Calcium, magnesium, potassium, and sodium oxybates in the FDA NDC Directory, including Jazz Pharmaceuticals, Inc..
What Calcium, magnesium, potassium, and sodium oxybates is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
XYWAV 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. • Idiopathic Hypersomnia (IH) in adults. 1.1 Narcolepsy XYWAV is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. …
— FDA label: Xywav, Jazz Pharmaceuticals, Inc., effective July 1, 2025. Read the full label on DailyMed →
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 →
Forms and how it is given
| Dosage forms | Solution |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Xywav |
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.
- Jazz Pharmaceuticals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA212690 XYWAV | Jazz | July 21, 2020 | 13, latest July 28, 2025 2025: REMS · 2025: REMS · 2024: REMS |
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) | 2393794, 2393795 |
|---|---|
| SPL set ID of the quoted label | 1e0ae43a-037f-42af-8e23-a0e51d75abe8 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA212690 |
| Active ingredients (FDA) | CALCIUM OXYBATE / MAGNESIUM OXYBATE / POTASSIUM OXYBATE / SODIUM OXYBATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Xywav, 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 →