Fludeoxyglucose F-18

Product NDC
40098-101
11-digit product format
400980101
Labeler code
40098
Product ID
40098-101_2b497301-b276-f7b2-e063-6294a90aa5d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fludeoxyglucose F-18
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Trustees of the University of Pennsylvania
Application
ANDA203801
Marketing category
ANDA
Marketing start
2014-10-30
Substance
FLUDEOXYGLUCOSE 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
Fludeoxyglucose F-18
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUDEOXYGLUCOSE F-18200 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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
99a01b5c-59f4-409d-9148-0a2993e6f287Product name120150507

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40098-101-19Fludeoxyglucose F-1825 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION2515

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40098-101FLUDEOXYGLUCOSE F-18 INJECTION, SOLUTION [TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA]15Current NDC, Legacy NDC, 1 package rows20250112_84f1aeab-685d-47fd-a8e9-e724979c4ce6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
40098-101-194009801011925 mL in 1 VIAL, MULTI-DOSE (40098-101-19) 25 ml2014-10-300000-00-00NoNoCurrent