Sodium Fluoride

Product NDC
62072-500
11-digit product format
620720500
Labeler code
62072
Product ID
62072-500_7fc6432d-a24e-4b2d-a8e4-a01cd43177f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM FLUORIDE F-18
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Kreitchman PET Center
Application
ANDA203936
Marketing category
ANDA
Marketing start
2016-05-23
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Fluoride
Brand name suffix
F 18
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE F-18200 mCi/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9L75099X6R

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d79dac3-9c48-45b0-a9b7-a8ef22ff9f55Product name120151112
9209e30a-83c7-4466-acf0-7533654a2b1cProduct name920151029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62072-500-30Sodium FluorideF 1830 mL in 1 VIAL, MULTI-DOSEINJECTION305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62072-500SODIUM FLUORIDE F 18 (SODIUM FLUORIDE F-18) INJECTION [KREITCHMAN PET CENTER]4Current NDC, Legacy NDC, 1 package rows20240113_df1389d2-1b9b-4327-856e-5ba38118d389.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62072-500-306207205003030 mL in 1 VIAL, MULTI-DOSE (62072-500-30) 30 ml2016-05-230000-00-00NoNoCurrent