FDA.reportPublic FDA data

Sodium Fluoride F 18

Product NDC
67939-020
11-digit product format
679390020
Labeler code
67939
Product ID
67939-020_d951aa31-f016-e2da-e053-2995a90a5b2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride F 18
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
The University of Utah DBA Cyclotron Radiochemistry Lab Huntsman Cancer Institute
Application
ANDA204497
Marketing category
ANDA
Marketing start
2012-07-11
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Fluoride F 18
Listing expiration
2026-12-31

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
2d79dac3-9c48-45b0-a9b7-a8ef22ff9f55Product name120151112
9209e30a-83c7-4466-acf0-7533654a2b1cProduct name920151029
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67939-020-10Sodium Fluoride F 1810 mL in 1 VIAL, MULTI-DOSEINJECTION108

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDE F-18ACTIVE INGREDIENT9L75099X6RSODIUM FLUORIDE F 18 (SODIUM FLUORIDE F 18) INJECTION [THE UNIVERSITY OF UTAH DBA CYCLOTRON RADIOCHEMISTRY LAB HUNTSMAN CANCER INSTITUTE]4
FLUORIDE ION F-18ACTIVE MOIETY4M4WE5N2GESODIUM FLUORIDE F 18 (SODIUM FLUORIDE F 18) INJECTION [THE UNIVERSITY OF UTAH DBA CYCLOTRON RADIOCHEMISTRY LAB HUNTSMAN CANCER INSTITUTE]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSODIUM FLUORIDE F 18 (SODIUM FLUORIDE F 18) INJECTION [THE UNIVERSITY OF UTAH DBA CYCLOTRON RADIOCHEMISTRY LAB HUNTSMAN CANCER INSTITUTE]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67939-020SODIUM FLUORIDE F 18 INJECTION [THE UNIVERSITY OF UTAH DBA CYCLOTRON RADIOCHEMISTRY LAB HUNTSMAN CANCER INSTITUTE]8Current NDC, Legacy NDC, 1 package rows20220304_2144e4e4-4be5-4fc6-b966-bd525ac7e430.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67939-020-106793900201010 mL in 1 VIAL, MULTI-DOSE (67939-020-10) 10 ml2012-07-110000-00-00NoNoCurrent