NDC 49609-101

Fludeoxyglucose F 18 300 mCi per 1 mL injection

On the label: SOFIE Co. dba SOFIE.

United States: 14

Where it's made

FactoryWhereRoleLast FDA inspection
N-Molecular Inc. dba SOFIEOakwood Village, OH, United StatesMakes it No problems foundJun 6, 2025 · 3 inspections
N-Molecular, Inc. dba SOFIEHaverhill, MA, United StatesMakes it Problems found, fixed voluntarilyNov 20, 2024 · 5 inspections, 1 with FDA action
N-Molecular, Inc. dba SOFIEColonie, NY, United StatesMakes it No problems foundFeb 5, 2026 · 4 inspections
SOFIE Co. dba SOFIESanford, FL, United StatesMakes it Problems found, fixed voluntarilyJan 22, 2024 · 4 inspections, 2 with FDA action
SOFIE Co. dba SOFIERomeoville, IL, United StatesMakes it Problems found, fixed voluntarilyJul 12, 2024 · 4 inspections
SOFIE Co. dba SOFIESterling, VA, United StatesMakes it Problems found, fixed voluntarilyJul 25, 2025 · 5 inspections
SOFIE Co. dba SOFIETotowa, NJ, United StatesMakes it Problems found, fixed voluntarilyAug 11, 2023 · 4 inspections
SOFIE Co. dba SOFIEKansas City, MO, United StatesMakes it Problems found, fixed voluntarilySep 3, 2025 · 4 inspections
SOFIE Co. dba SOFIEGilroy, CA, United StatesMakes it Problems found, fixed voluntarilyAug 7, 2025 · 4 inspections
SOFIE Co. dba SOFIEMorgantown, WV, United StatesMakes it Problems found, fixed voluntarilyAug 28, 2025 · 4 inspections
SOFIE Co. dba SOFIEDallas, TX, United StatesMakes it Problems found, fixed voluntarilyApr 21, 2026 · 4 inspections
SOFIE Co. dba SOFIEHouston, TX, United StatesMakes it Problems found, fixed voluntarilyOct 28, 2025 · 4 inspections
SOFIE Co. dba SOFIESomerset, NJ, United StatesMakes it Problems found, fixed voluntarilyJan 20, 2023 · 4 inspections
SOFIE Co. dba SOFIEDecatur, IL, United StatesMakes it Problems found, fixed voluntarilyJan 15, 2026 · 4 inspections

Product details

Generic drug
Fludeoxyglucose F-18: every company that makes it
Form
injection, intravenous
Strength
300 mCi per 1 mL
Approval
ANDA ANDA203591
On the market since
Dec 8, 2011
Package NDCs
49609-101-01 49609-101-02
Official label
DailyMed (National Library of Medicine), updated Oct 26, 2026

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