Sodium Fluoride F 18

Product NDC
60055-623
11-digit product format
600550623
Labeler code
60055
Product ID
60055-623_11315b95-d5f0-4960-98e6-43fcf54daeb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride F 18
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
JUBILANT DRAX IMAGE RADIOPHARMACIES, INC. DBA JUBILANT RADIOPHARMA
Application
ANDA203968
Marketing category
ANDA
Marketing start
2011-01-26
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
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60055-623-302022-02-02C16284748780-1d6a99b39-65de-a426-e053-dadaa90af4c21ab87313-f82a-4819-9e32-f1320a747fef
60055-623-302022-01-28C16284748780-1d6a99b39-65de-a426-e053-dadaa90af4c21ab87313-f82a-4819-9e32-f1320a747fef

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60055-623-306005506233030 mL in 1 VIAL (60055-623-30) 30 ml2015-09-010000-00-00NoNoCurrent