NDC 0469-0647
Astagraf XL 0.5 mg capsule, coated, extended release
On the label: Astellas Pharma US, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Astellas Ireland Co., Ltd. | Killorglin, Ireland | Makes it and tests it | Problems found, fixed voluntarilySep 2, 2022 · 5 inspections |
| Astellas Pharma Inc. | Toyama, Japan | Makes it, makes the active ingredient and tests it | No problems foundApr 18, 2024 · 6 inspections |
Recalls
- Dec 23, 2024 · Class I · Astellas Pharma US Inc.
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Lots: Lot# 0R3092A, EXP 03/31/2026
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Tacrolimus: every company that makes it
- Form
- capsule, coated, extended release, oral
- Strength
- 0.5 mg
- Approval
- NDA NDA204096
- On the market since
- Jul 19, 2013
- Package NDCs
0469-0647-110469-0647-73- Official label
- DailyMed (National Library of Medicine), updated Jan 14, 2026
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