Fludeoxyglucose

Product NDC
69587-001
11-digit product format
695870001
Labeler code
69587
Product ID
69587-001_2baf0278-7e18-4db0-e063-6294a90ae9de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fludeoxyglucose F18
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
MIPS Cyclotron & Radiochemistry Facility
Application
ANDA204472
Marketing category
ANDA
Marketing start
2015-02-28
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
99a01b5c-59f4-409d-9148-0a2993e6f287Product name120150507

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69587-001-01FludeoxyglucoseF1830 mL in 1 VIAL, GLASSINJECTION3022

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUDEOXYGLUCOSE F-18ACTIVE INGREDIENT0Z5B2CJX4DFLUDEOXYGLUCOSE F18 INJECTION [MIPS CYCLOTRON & RADIOCHEMISTRY FACILITY]2
FLUDEOXYGLUCOSE F-18ACTIVE MOIETY0Z5B2CJX4DFLUDEOXYGLUCOSE F18 INJECTION [MIPS CYCLOTRON & RADIOCHEMISTRY FACILITY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69587-001FLUDEOXYGLUCOSE F18 INJECTION [MIPS CYCLOTRON & RADIOCHEMISTRY FACILITY]22Current NDC, Legacy NDC, 1 package rows20250116_0ec2d4d1-b295-18dc-e054-00144ff88e88.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69587-001-016958700010130 mL in 1 VIAL, GLASS (69587-001-01) 30 ml2018-12-210000-00-00NoNoCurrent