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Brand-name prescription medicine

Daybue

Generic name: Trofinetide

FDA application holder: Acadia Pharms Inc

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

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

Quick answers

What is Daybue?
Daybue is a brand name of Trofinetide, a prescription medicine. The FDA NDC Directory lists 1 Daybue product in 1 strength and form.
Who makes Daybue?
Acadia Pharms Inc holds the FDA application for Daybue (NDA217026, approved March 10, 2023).
Is there a generic or store brand of Daybue?
Other products of Trofinetide are listed with the FDA, but none in exactly the same strength and form as a Daybue product.
Has Daybue been recalled?
No recall linked to Daybue products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Daybue is

Each Daybue product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.

Trofinetide · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
trofinetide 200 mg/mL
solution (oral)
Daybue None listed DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Trofinetide →

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of Daybue products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA217026Acadia Pharms IncMarch 10, 20231

Companies that list Daybue

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Daybue products.

Recalls

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

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, 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. NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026

Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.

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