Sodium Fluoride

Product NDC
49609-002
11-digit product format
496090002
Labeler code
49609
Product ID
49609-002_a5133702-87ed-40f9-e053-2995a90ad385
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM FLUORIDE F-18
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
SOFIE Co. dba SOFIE
Application
ANDA203544
Marketing category
ANDA
Marketing start
2011-12-08
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE F-18
Active strength
200 mCi/mL
Pharmacologic classes
Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49609-002-014960900020130 mL in 1 VIAL, GLASS (49609-002-01) 30 ml2011-12-080000-00-00NoNoCurrent