Astellas Pharma US, Inc.
NDC labeler codes: 0469, 82829
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- TacrolimusPrograf, Envarsus XR, Astagraf XL · 9 products
- EnzalutamideXtandi · 5 products
- FezolinetantVeozah · 3 products
- MirabegronMyrbetriq, Mirabgeorn · 3 products
- Isavuconazonium sulfateCresemba · 3 products
- ZolbetuximabVyloy · 2 products
- Avacincaptad pegolIzervay · 1 product
- RegadenosonLexiscan · 1 product
- GilteritinibXospata · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| October 18, 2024 | BLA761365 | Zolbetuximab VYLOY | Astellas |
| August 4, 2023 | NDA217225 | Avacincaptad pegol IZERVAY | Astellas |
| May 12, 2023 | NDA216578 | Fezolinetant VEOZAH | Astellas |
| March 25, 2021 | NDA213801 | Mirabegron MYRBETRIQ GRANULES | Apgdi |
| August 4, 2020 | NDA213674 | Enzalutamide XTANDI | Astellas |
| November 28, 2018 | NDA211349 | Gilteritinib XOSPATA | Astellas |
| May 24, 2018 | NDA210115 | Tacrolimus PROGRAF | Astellas |
| March 6, 2015 | NDA207500 | Isavuconazonium sulfate CRESEMBA | Astellas |
| March 6, 2015 | NDA207501 | Isavuconazonium sulfate CRESEMBA | Astellas |
| July 19, 2013 | NDA204096 | Tacrolimus ASTAGRAF XL | Astellas |
| August 31, 2012 | NDA203415 | Enzalutamide XTANDI | Astellas |
| June 28, 2012 | NDA202611 | Mirabegron MYRBETRIQ | Apgdi |
| April 10, 2008 | NDA022161 | Regadenoson LEXISCAN | Astellas |
| April 8, 1994 | NDA050708 | Tacrolimus PROGRAF | Astellas |
| April 8, 1994 | NDA050709 | Tacrolimus PROGRAF | Astellas |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2024
-
December 23, 2024 · Class I · Ongoing · D-0211-2025 · Tacrolimus
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.
-
December 23, 2024 · Class I · Ongoing · D-0210-2025 · Tacrolimus
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.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
- All drug companiesA to Z
- All prescription drugs A to ZSearch by generic, brand or Spanish name
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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026