Fludeoxyglucose F 18

Product NDC
67939-010
11-digit product format
679390010
Labeler code
67939
Product ID
67939-010_d93db56f-430e-5490-e053-2995a90ace22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fludeoxyglucose F 18
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
The University of Utah DBA Cyclotron Radiochemistry Lab / Huntsman Cancer Institute
Application
ANDA204498
Marketing category
ANDA
Marketing start
2013-11-01
Substance
FLUDEOXYGLUCOSE F-18
Active strength
300 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
Fludeoxyglucose F 18
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUDEOXYGLUCOSE F-18300 mCi/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0Z5B2CJX4D

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a8297d3a-f6a8-4d2b-8fce-c063a35f1186Product name220251210
858c9b08-fb6b-48b9-8516-ea929654e228Product name220160606
6d7dfd10-cccc-49a1-a5c7-1842491e3644Product name220151125
b370ef4e-503e-4658-af90-e40f1dd3ff26Product name920151106
a838cd4c-e408-4023-a03d-912949043ddcProduct name220151029
bce34a5c-800a-42cd-a264-d5a0d09eed8aProduct name120150902
99a01b5c-59f4-409d-9148-0a2993e6f287Product name120150507

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67939-010-50Fludeoxyglucose F 1850 mL in 1 VIAL, MULTI-DOSEINJECTION5016

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67939-010FLUDEOXYGLUCOSE F 18 INJECTION [THE UNIVERSITY OF UTAH DBA CYCLOTRON RADIOCHEMISTRY LAB / HUNTSMAN CANCER INSTITUTE]16Current NDC, Legacy NDC, 1 package rows20220303_4439286d-2b7b-4403-9e4a-3b0aad10ad5b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67939-010-506793900105050 mL in 1 VIAL, MULTI-DOSE (67939-010-50) 50 ml2020-05-200000-00-00NoNoCurrent