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Prescription medicine

Zuranolone

Brand names: Zurzuvae

Drug class: Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

YesBoxed warning
None listedFDA shortage list
0Recalls (FDA reports)
1Companies
2023First FDA approval on file

Quick answers

What is Zuranolone used for?
The FDA-approved label (Zurzuvae, Biogen MA Inc., June 15, 2026) says: “ZURZUVAE is indicated for the treatment of postpartum depression (PPD) in adults. ZURZUVAE is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of postpartum depression (PPD) in adults.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Zuranolone have a boxed warning?
Yes. The FDA label for Zurzuvae has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Zuranolone?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Zuranolone been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Zuranolone?
1 company lists prescription products of Zuranolone in the FDA NDC Directory, including Biogen MA Inc..

What Zuranolone is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

ZURZUVAE is indicated for the treatment of postpartum depression (PPD) in adults. ZURZUVAE is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of postpartum depression (PPD) in adults.

— FDA label: Zurzuvae, Biogen MA Inc., effective June 15, 2026. 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.

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 formsCapsule
RouteOral
Prescription products3 in the FDA NDC Directory
Brand namesZurzuvae

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.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA217369
ZURZUVAE		 BiogenAugust 4, 2023 2, latest April 20, 2026
2026: Labeling · 2024: Labeling

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)2669910, 2669916, 2669918, 2669920, 2669922, 2669924
SPL set ID of the quoted labelf18e53b0-d0bb-422d-8de7-ab64b7292b29
FDA labels (SPL)1
FDA applicationsNDA217369
Active ingredients (FDA)ZURANOLONE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Zurzuvae, Biogen MA Inc., effective June 15, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

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