Quick answers
- What is Astagraf XL?
- Astagraf XL is a brand name of Tacrolimus, a prescription medicine. The FDA NDC Directory lists 3 Astagraf XL products in 3 strengths and forms.
- Who makes Astagraf XL?
- Astellas holds the FDA application for Astagraf XL (NDA204096, approved July 19, 2013).
- Is there a generic or store brand of Astagraf XL?
- Yes. The FDA NDC Directory lists 3 other products with the same active ingredients, strength and form as a Astagraf XL product, 3 of them generic. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for Astagraf XL?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 2 Astagraf XL 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 Astagraf XL been recalled?
- FDA enforcement reports list 1 recall of Astagraf XL products; the newest started December 23, 2024. A recall usually concerns specific lots, not every product.
What Astagraf XL is
Each Astagraf XL 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 form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| tacrolimus 0.5 mg capsule, coated, extended release (oral) | Astagraf XL | 1 product, 1 company | DailyMed |
| tacrolimus 1 mg capsule, coated, extended release (oral) | Astagraf XL | 1 product, 1 company | DailyMed |
| tacrolimus 5 mg capsule, coated, extended release (oral) | Astagraf XL | 1 product, 1 company | 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.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA204096 | Astellas | July 19, 2013 | 3 |
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.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| tacrolimus 0.5 mg capsule, coated, extended release | Brand: Astagraf XL | $2.88 per capsule |
| tacrolimus 1 mg capsule, coated, extended release | Brand: Astagraf XL | $5.71 per capsule |
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 Astagraf XL
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Astagraf XL products.
- Astellas Pharma US, Inc.3 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.
-
December 23, 2024 · Class I · Ongoing · D-0210-2025
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73. — Astellas Pharma US Inc.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- 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.