Sodium Fluoride F 18

Product NDC
13108-211
11-digit product format
131080211
Labeler code
13108
Product ID
13108-211_b7c47299-7723-0b71-e053-2a95a90acdfd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride F 18
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
NukeMed, Inc. dba SpectronRx
Application
ANDA203912
Marketing category
ANDA
Marketing start
2015-04-24
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
13108-211-10131080211101 mL in 1 VIAL, GLASS (13108-211-10) 1 ml2015-04-240000-00-00NoNoCurrent
13108-211-25131080211251 mL in 1 VIAL, GLASS (13108-211-25) 1 ml2015-04-240000-00-00NoNoCurrent
13108-211-30131080211301 mL in 1 VIAL, GLASS (13108-211-30) 1 ml2015-04-240000-00-00NoNoCurrent
13108-211-50131080211501 mL in 1 VIAL, GLASS (13108-211-50) 1 ml2015-04-240000-00-00NoNoCurrent