Fludeoxyglucose

Product NDC
13267-234
11-digit product format
132670234
Labeler code
13267
Product ID
13267-234_6586ed67-0b87-4046-a7c1-274d39c10922
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fludeoxyglucose F18
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
Application
NDA021870
Marketing category
NDA
Marketing start
2005-08-19
Substance
FLUDEOXYGLUCOSE F-18
Active strength
400 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-18400 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
13267-234-45FludeoxyglucoseF1825 mL in 1 VIAL, GLASSINJECTION2520231214

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUDEOXYGLUCOSE F-18ACTIVE INGREDIENT0Z5B2CJX4DFLUDEOXYGLUCOSE F18 INJECTION [THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH]1
FLUDEOXYGLUCOSE F-18ACTIVE MOIETY0Z5B2CJX4DFLUDEOXYGLUCOSE F18 INJECTION [THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13267-234FLUDEOXYGLUCOSE F18 INJECTION [THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH]20231214Current NDC, Legacy NDC, 1 package rows20231215_dfd91498-4bfc-4d45-a9a3-cee6153ae573.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13267-234-451326702344525 mL in 1 VIAL, GLASS (13267-234-45) 25 ml2005-08-190000-00-00NoNoCurrent