Medical emergency?Emergency? Call 911. Nearest emergency roomsNearest ERs

Brand-name prescription medicine

Prograf

Generic name: Tacrolimus

FDA application holder: Astellas

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 Prograf?
Prograf is a brand name of Tacrolimus, a prescription medicine. The FDA NDC Directory lists 6 Prograf products in 6 strengths and forms.
Who makes Prograf?
Astellas holds the FDA application for Prograf (NDA050708, approved April 8, 1994).
Is there a generic or store brand of Prograf?
Yes. The FDA NDC Directory lists 6 other products with the same active ingredients, strength and form as a Prograf product, 6 of them generic. Ask your pharmacist whether one is right for you.
What do pharmacies pay for Prograf?
CMS lists a National Average Drug Acquisition Cost (NADAC) for 4 Prograf strengths and forms (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
Has Prograf been recalled?
FDA enforcement reports list 1 recall of Prograf products; the newest started December 23, 2024. A recall usually concerns specific lots, not every product.

What Prograf is

Each Prograf 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 0.2 mg
granule, for suspension (oral)
Prograf None listed DailyMed
tacrolimus 0.5 mg
capsule, gelatin coated (oral)
Prograf 2 products, 2 companies DailyMed
tacrolimus 1 mg
capsule, gelatin coated (oral)
Prograf 2 products, 2 companies DailyMed
tacrolimus 1 mg
granule, for suspension (oral)
Prograf None listed DailyMed
tacrolimus 5 mg
capsule, gelatin coated (oral)
Prograf 2 products, 2 companies DailyMed
tacrolimus 5 mg/mL
injection, solution (intravenous)
Prograf 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 Prograf products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA050708AstellasApril 8, 19943
NDA050709AstellasApril 8, 19941
NDA210115AstellasMay 24, 20182

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Prograf, by strength and form
Strength and formGeneric or brandPharmacies pay
tacrolimus 0.2 mg
granule, for suspension
Brand: Prograf $5.02 per unit
tacrolimus 0.5 mg
capsule, gelatin coated
Brand: Prograf $3.66 per capsule
Generic of the same strength and form: $0.1192 per capsule
tacrolimus 1 mg
capsule, gelatin coated
Brand: Prograf $7.34 per capsule
Generic of the same strength and form: $0.1598 per capsule
tacrolimus 1 mg
granule, for suspension
Brand: Prograf $7.44 per unit

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list Prograf

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

Recalls

From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. December 23, 2024 · Class I · Ongoing · D-0211-2025

    Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

    Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73. — Astellas Pharma US Inc.

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.

Report an error → · Information for medicine makers