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Brand-name prescription medicine

Sandimmune

Generic name: Cyclosporine

FDA application holder: Novartis

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 Sandimmune?
Sandimmune is a brand name of Cyclosporine, a prescription medicine. The FDA NDC Directory lists 3 Sandimmune products in 3 strengths and forms.
Who makes Sandimmune?
Novartis holds the FDA application for Sandimmune (NDA050573, approved November 14, 1983).
Is there a generic or store brand of Sandimmune?
Yes. The FDA NDC Directory lists 16 other products with the same active ingredients, strength and form as a Sandimmune product, 14 of them generic. Ask your pharmacist whether one is right for you.
Has Sandimmune been recalled?
No recall linked to Sandimmune products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Sandimmune is

Each Sandimmune 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.

Cyclosporine · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
cyclosporine 100 mg
capsule, liquid filled (oral)
Sandimmune 8 products, 8 companies DailyMed
cyclosporine 25 mg
capsule, liquid filled (oral)
Sandimmune 8 products, 8 companies DailyMed
cyclosporine 50 mg/mL
injection (intravenous)
Sandimmune None listed DailyMed

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

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of Sandimmune products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA050573NovartisNovember 14, 19831
NDA050625NovartisMarch 2, 19902

Companies that list Sandimmune

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

Recalls

No recall linked to Sandimmune 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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