Data / Drug companies / Astellas Pharma US, Inc.
Astellas Pharma US, Inc.: 29 products in the FDA NDC directory, labeler code 0469
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Astellas Pharma US, Inc. (labeler code 0469) lists 29 products in the FDA National Drug Code Directory, covering 9 finished drugs by generic name. By type: 27 prescription drugs, 2 bulk ingredients. Its main marketing category is new drug applications (NDA). The newest product started marketing on April 24, 2025.
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- Labeler code
- 0469
- Products in commercial distribution
- 29
- Packages
- 36
- Finished drugs by generic name
- 9
- Prescription products
- 27
- Over the counter products
- 0
- Flagged as original packager
- 26 of 26 products that carry the flag
- Started marketing in the last 12 months
- 0
- Earliest marketing start
- April 8, 1994
- openFDA record search
- api.fda.gov
Products by marketing category
Share of the company's products in commercial distribution.
| Marketing category | Products | Share |
|---|---|---|
| New drug applications (NDA) | 25 | 86.2% |
| Biologics (BLA) | 2 | 6.9% |
| Bulk ingredients for compounding | 1 | 3.4% |
| Bulk ingredients | 1 | 3.4% |
Products by type
| Type | Products | Share |
|---|---|---|
| Prescription drugs | 27 | 93.1% |
| Bulk ingredients | 2 | 6.9% |
Drugs it lists
Finished drugs by generic name, with how many companies list each.
| Drug | Products | Companies listing it |
|---|---|---|
| Tacrolimus | 6 | 35 |
| Enzalutamide | 5 | 1 |
| Isavuconazonium sulfate | 3 | 1 |
| Mirabegron | 3 | 10 |
| Tacrolimus extended-release capsules | 3 | 2 |
| Fezolinetant | 3 | 1 |
| Zolbetuximab | 2 | 1 |
| Gilteritinib | 1 | 1 |
| Regadenoson | 1 | 14 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 4 | 13.8% |
| Capsule | 4 | 13.8% |
| Capsule, gelatin coated | 3 | 10.3% |
| Capsule, coated, extended release | 3 | 10.3% |
| Tablet, film coated | 3 | 10.3% |
| Injection, powder, for suspension | 2 | 6.9% |
| Powder | 2 | 6.9% |
| Tablet, film coated, extended release | 2 | 6.9% |
| Injection, solution | 2 | 6.9% |
| Granule, for suspension | 2 | 6.9% |
| Granule, for suspension, extended release | 1 | 3.4% |
| Injection, powder, lyophilized, for solution | 1 | 3.4% |
Pharmacologic classes
FDA established pharmacologic classes of its products.
| Class | Products |
|---|---|
| Calcineurin Inhibitor Immunosuppressant | 9 |
| Androgen Receptor Inhibitor | 5 |
| Azole Antifungal | 3 |
| beta3-Adrenergic Agonist | 3 |
| Neurokinin 3 Receptor Antagonist | 3 |
| Claudin 18.2-directed Cytolytic Antibody | 2 |
| Adenosine Receptor Agonist | 1 |
Newest products
By marketing start date.
| Product | Product NDC | Dosage form | Marketing category | Marketing start |
|---|---|---|---|---|
| Vyloy | 0469-4425 | Injection, powder, for suspension | Biologics (BLA) | April 24, 2025 |
| Vyloy | 0469-3425 | Injection, powder, for suspension | Biologics (BLA) | October 24, 2024 |
| Veozah | 0469-2460 | Tablet, film coated | New drug applications (NDA) | May 16, 2023 |
| Veozah | 0469-2760 | Tablet, film coated | New drug applications (NDA) | May 12, 2023 |
| Veozah | 0469-2660 | Tablet, film coated | New drug applications (NDA) | May 12, 2023 |
| Cresemba | 0469-2860 | Capsule | New drug applications (NDA) | November 22, 2022 |
| Myrbetriq | 0469-5020 | Granule, for suspension, extended release | New drug applications (NDA) | March 25, 2021 |
| Xtandi | 0469-1725 | Tablet | New drug applications (NDA) | August 4, 2020 |
| Xtandi | 0469-0725 | Tablet | New drug applications (NDA) | August 4, 2020 |
| Xtandi | 0469-0625 | Tablet | New drug applications (NDA) | August 4, 2020 |
| Xospata | 0469-1425 | Tablet | New drug applications (NDA) | November 29, 2018 |
| Prograf | 0469-1330 | Granule, for suspension | New drug applications (NDA) | May 24, 2018 |
| Prograf | 0469-1230 | Granule, for suspension | New drug applications (NDA) | May 24, 2018 |
| Cresemba | 0469-0520 | Capsule | New drug applications (NDA) | November 4, 2015 |
| Isavuconazonium sulfate | 0469-1020 | Powder | Bulk ingredients for compounding | March 6, 2015 |
| Cresemba | 0469-0420 | Injection, powder, lyophilized, for solution | New drug applications (NDA) | March 6, 2015 |
| Astagraf xl | 0469-0687 | Capsule, coated, extended release | New drug applications (NDA) | July 19, 2013 |
| Astagraf xl | 0469-0677 | Capsule, coated, extended release | New drug applications (NDA) | July 19, 2013 |
| Astagraf xl | 0469-0647 | Capsule, coated, extended release | New drug applications (NDA) | July 19, 2013 |
| Xtandi | 0469-1125 | Capsule | New drug applications (NDA) | August 31, 2012 |
| Xtandi | 0469-0125 | Capsule | New drug applications (NDA) | August 31, 2012 |
| Mirabegron | 0469-2603 | Powder | Bulk ingredients | June 28, 2012 |
| Myrbetriq | 0469-2602 | Tablet, film coated, extended release | New drug applications (NDA) | June 28, 2012 |
| Myrbetriq | 0469-2601 | Tablet, film coated, extended release | New drug applications (NDA) | June 28, 2012 |
| Lexiscan | 0469-6501 | Injection, solution | New drug applications (NDA) | April 10, 2008 |
CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.