FDA.reportPublic FDA data

Fludeoxyglucose

Product NDC
60215-411
11-digit product format
602150411
Labeler code
60215
Product ID
60215-411_4041af0a-011f-ddc6-e063-6394a90af478
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fludeoxyglucose F18
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
The University of Texas MD Anderson Cancer Center
Application
ANDA203246
Marketing category
ANDA
Marketing start
2011-12-06
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
Brand name suffix
F18
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
99a01b5c-59f4-409d-9148-0a2993e6f287Product name120150507

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60215-411-152025-02-25C16284748780-12cef2736-9e43-d83d-e063-dadaa90ab31fHIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Fludeoxyglucose F18 Injection safely and effectively. See full prescribing information for Fludeoxyglucose F18 Injection. Fludeoxyglucose F18 Injection Initial U.S. Approval: 2005
60215-411-302025-02-25C16284748780-12cef2736-9e43-d83d-e063-dadaa90ab31fHIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Fludeoxyglucose F18 Injection safely and effectively. See full prescribing information for Fludeoxyglucose F18 Injection. Fludeoxyglucose F18 Injection Initial U.S. Approval: 2005
60215-411-152025-01-30C16284748780-12cef2736-9e43-d83d-e063-dadaa90ab31fHIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Fludeoxyglucose F18 Injection safely and effectively. See full prescribing information for Fludeoxyglucose F18 Injection. Fludeoxyglucose F18 Injection Initial U.S. Approval: 2005
60215-411-302025-01-30C16284748780-12cef2736-9e43-d83d-e063-dadaa90ab31fHIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Fludeoxyglucose F18 Injection safely and effectively. See full prescribing information for Fludeoxyglucose F18 Injection. Fludeoxyglucose F18 Injection Initial U.S. Approval: 2005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60215-411-30FludeoxyglucoseF1827 mL in 1 VIAL, GLASSINJECTION278

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUDEOXYGLUCOSE F-18ACTIVE INGREDIENT0Z5B2CJX4DFLUDEOXYGLUCOSE F18 INJECTION [THE UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER]4
FLUDEOXYGLUCOSE F-18ACTIVE MOIETY0Z5B2CJX4DFLUDEOXYGLUCOSE F18 INJECTION [THE UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFLUDEOXYGLUCOSE F18 INJECTION [THE UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRFLUDEOXYGLUCOSE F18 INJECTION [THE UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER]4
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37FLUDEOXYGLUCOSE F18 INJECTION [THE UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60215-411FLUDEOXYGLUCOSE F18 INJECTION [THE UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER]7Current NDC, Legacy NDC, 1 package rows20250227_43954e40-bb95-4275-92ab-96211b7de907.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60215-411-156021504111515 mL in 1 VIAL, GLASS (60215-411-15) 15 ml2011-12-060000-00-00NoNoCurrent
60215-411-306021504113027 mL in 1 VIAL, GLASS (60215-411-30) 27 ml2011-12-060000-00-00NoNoCurrent