Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| N-Molecular Inc. dba SOFIE | Oakwood Village, OH, United States | Makes it | No problems foundJun 6, 2025 · 3 inspections |
| N-Molecular, Inc. dba SOFIE | Haverhill, MA, United States | Makes it | Problems found, fixed voluntarilyNov 20, 2024 · 5 inspections, 1 with FDA action |
| SOFIE Co. dba SOFIE | Sanford, FL, United States | Makes it | Problems found, fixed voluntarilyJan 22, 2024 · 4 inspections, 2 with FDA action |
| SOFIE Co. dba SOFIE | Romeoville, IL, United States | Makes it | Problems found, fixed voluntarilyJul 12, 2024 · 4 inspections |
| SOFIE Co. dba SOFIE | Sterling, VA, United States | Makes it | Problems found, fixed voluntarilyJul 25, 2025 · 5 inspections |
| SOFIE Co. dba SOFIE | Kansas City, MO, United States | Makes it | Problems found, fixed voluntarilySep 3, 2025 · 4 inspections |
| SOFIE Co. dba SOFIE | Gilroy, CA, United States | Makes it | Problems found, fixed voluntarilyAug 7, 2025 · 4 inspections |
| SOFIE Co. dba SOFIE | Morgantown, WV, United States | Makes it | Problems found, fixed voluntarilyAug 28, 2025 · 4 inspections |
| SOFIE Co. dba SOFIE | Dallas, TX, United States | Makes it | Problems found, fixed voluntarilyApr 21, 2026 · 4 inspections |
| SOFIE Co. dba SOFIE | Somerset, NJ, United States | Makes it | Problems found, fixed voluntarilyJan 20, 2023 · 4 inspections |
Product details
- Generic drug
- Fluoride Ion F-18: every company that makes it
- Form
- injection, intravenous
- Strength
- 200 mCi per 1 mL
- Approval
- ANDA ANDA203592
- On the market since
- Dec 8, 2011
- Package NDCs
49609-102-01- Official label
- DailyMed (National Library of Medicine), updated Oct 23, 2026
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