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Brand-name prescription medicine

Envarsus XR

Generic name: Tacrolimus

FDA application holder: Veloxis Pharms Inc

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
2015FDA approval
0Recalls (FDA reports)

Quick answers

What is Envarsus XR?
Envarsus XR is a brand name of Tacrolimus, a prescription medicine. The FDA NDC Directory lists 3 Envarsus XR products in 3 strengths and forms.
Who makes Envarsus XR?
Veloxis Pharms Inc holds the FDA application for Envarsus XR (NDA206406, approved July 10, 2015).
Is there a generic or store brand of Envarsus XR?
Other products of Tacrolimus are listed with the FDA, but none in exactly the same strength and form as a Envarsus XR product.
Has Envarsus XR been recalled?
No recall linked to Envarsus XR products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Envarsus XR is

Each Envarsus XR 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.

Tacrolimus · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
tacrolimus 0.75 mg
tablet, extended release (oral)		 Envarsus XR None listed DailyMed
tacrolimus 1 mg
tablet, extended release (oral)		 Envarsus XR None listed DailyMed
tacrolimus 4 mg
tablet, extended release (oral)		 Envarsus XR None listed DailyMed

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

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of Envarsus XR products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA206406Veloxis Pharms IncJuly 10, 20153

Companies that list Envarsus XR

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

Recalls

No recall linked to Envarsus XR 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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