Labeler · US market
Astellas Pharma US, Inc.
Astellas Pharma US, Inc. is a US drug labeler with US FDA registrations covering 25 drug concepts (22 currently active) across 47 packages. It is currently the only active US supplier of 13 drugs. The company files with FDA under 2 name variants, merged into this profile.
Also files as: Astellas Pharma Inc.
ACTIVE - US
openFDA · updated weekly
Labeler codes0469 · 12838 · 51248 · 82829
Active drugs22
Registrations36 active / 40
Packages47
Sole supplier of13 drugs
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FDA filings tell us what Astellas Pharma US, Inc. registers, not who it is. If you know this company - what it makes, who owns it, where it manufactures - you can add it. Every submission is reviewed before it goes live.
Submit information about this company →Portfolio25 drugs · US
Every drug concept this labeler has US registrations for, by package count.
| Drug | Type | NDCs | Packages | Status |
|---|---|---|---|---|
| Mirabegron tablet, film coated, extended release | rx | 2 | 6 | SUPPLYING |
| Fezolinetant tablet, film coated | rx | 3 | 4 | SUPPLYING |
| Tacrolimus Extended-Release Capsules capsule, coated, extended release | rx | 3 | 3 |