NDC 64725-0515
Intuniv 2 mg tablet, extended release
On the label: TYA Pharmaceuticals. It's repackaged: TYA Pharmaceuticals rebottles it from Takeda Pharmaceuticals America, Inc.'s NDC 54092-515.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Industriale Chimica SRL | Saronno, Italy | Makes the active ingredient | Problems found, fixed voluntarilyOct 17, 2025 · 6 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 |
| Pharmazell (India) Private Limited | Anakapalli, India | Makes the active ingredient | Problems found, fixed voluntarilyFeb 7, 2025 · 4 inspections |
| Quimica Sintetica Sa | Alcala De Henares, Spain | Makes the active ingredient | Problems found, fixed voluntarilyApr 23, 2025 · 6 inspections |
| Mayne Pharma International Pty Ltd. | Salisbury South, Australia | Tests it | Problems found, fixed voluntarilyMar 21, 2025 · 6 inspections |
| Pace Analytical Life Sciences, LLC | Morrisville, NC, United States | Tests it | No problems foundJul 10, 2026 · 1 inspection |
| Sharp Packaging Services, LLC | Conshohocken, PA, United States | Packages it and labels it | No problems foundFeb 6, 2026 · 8 inspections |
| Sharp Packaging Services, LLC | Allentown, PA, United States | Packages it, labels it and sterilizes it | No problems foundNov 21, 2025 · 7 inspections |
Repackaging site
- TYA Pharmaceuticals, Location not on file · repackages it and relabels it
Product details
- Generic drug
- Guanfacine: every company that makes it
- Form
- tablet, extended release
- Strength
- 2 mg
- Approval
- NDA NDA022037
- On the market since
- Sep 2, 2009
- Package NDCs
64725-0515-1- Official label
- DailyMed (National Library of Medicine), updated Aug 31, 2013
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