Sodium Fluoride F 18

Product NDC
76419-211
11-digit product format
764190211
Labeler code
76419
Product ID
76419-211_99e70a20-1679-16e4-e053-2995a90a80a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM FLUORIDE F-18
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hot Shots NM, LLC dba Midwest Positron Technology, LC
Application
ANDA204530
Marketing category
ANDA
Marketing start
2014-08-21
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
2020-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76419-211-107641902111010 mL in 1 VIAL, GLASS (76419-211-10) 10 ml2014-08-210000-00-00NoNoCurrent
76419-211-257641902112525 mL in 1 VIAL, GLASS (76419-211-25) 25 ml2014-08-210000-00-00NoNoCurrent
76419-211-307641902113030 mL in 1 VIAL, GLASS (76419-211-30) 30 ml2014-08-210000-00-00NoNoCurrent
76419-211-507641902115050 mL in 1 VIAL, GLASS (76419-211-50) 50 ml2014-08-210000-00-00NoNoCurrent