NDC 54092-385
AdderallXR 4 ingredients capsule, extended release
On the label: Takeda Pharmaceuticals America, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Cambrex Charles City, Inc | Charles City, IA, United States | Makes the active ingredient | Problems found, fixed voluntarilyMar 7, 2025 · 8 inspections |
| Patheon Manufacturing Services LLC | Greenville, NC, United States | Makes it, tests it, packages it and labels it | No problems foundSep 26, 2025 · 11 inspections |
| Unither Manufacturing LLC | Rochester, NY, United States | Makes it and tests it | Serious problems, FDA actionMay 15, 2026 · 8 inspections, 1 with FDA action |
| Sharp Packaging Services, LLC | Allentown, PA, United States | Packages it and labels it | No problems foundNov 21, 2025 · 7 inspections |
Product details
- Generic drug
- Amphetamine and Dextroamphetamine: every company that makes it
- Form
- capsule, extended release, oral
- Strength
- 4 ingredients
- Approval
- NDA NDA021303
- On the market since
- May 22, 2002
- Package NDCs
54092-385-01- Official label
- DailyMed (National Library of Medicine), updated Apr 30, 2026
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