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Brand-name prescription medicine

Vykoura

Generic name: Leucovorin calcium

FDA application holder: Avyxa Holdings

Strengths and generic versions Official label

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.

At a glance

3Strengths and forms
0Same medicine, other names
2026FDA approval
0Recalls (FDA reports)

Quick answers

What is Vykoura?
Vykoura is a brand name of Leucovorin calcium, a prescription medicine. The FDA NDC Directory lists 3 Vykoura products in 3 strengths and forms.
Who makes Vykoura?
Avyxa Holdings holds the FDA application for Vykoura (NDA220406, approved February 3, 2026).
Is there a generic or store brand of Vykoura?
Other products of Leucovorin calcium are listed with the FDA, but none in exactly the same strength and form as a Vykoura product.
Has Vykoura been recalled?
No recall linked to Vykoura products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Vykoura is

Each Vykoura 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.

Leucovorin calcium · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
leucovorin calcium 350 mg/35 mL
injection (intramuscular, intravenous)		 Vykoura None listed DailyMed
leucovorin calcium 50 mg/5 mL
injection (intramuscular, intravenous)		 Vykoura None listed DailyMed
leucovorin calcium 500 mg/50 mL
injection (intramuscular, intravenous)		 Vykoura None listed DailyMed

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

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of Vykoura products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA220406Avyxa HoldingsFebruary 3, 20263

Companies that list Vykoura

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

Recalls

No recall linked to Vykoura 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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