Fludeoxyglucose F 18

Product NDC
73410-003
11-digit product format
734100003
Labeler code
73410
Product ID
73410-003_34012195-5fcd-eff1-e063-6294a90a98de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fludeoxyglucose F 18
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
SOFIE Co. dba SOFIE
Application
ANDA204463
Marketing category
ANDA
Marketing start
2019-11-06
Substance
FLUDEOXYGLUCOSE F-18
Active strength
20 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-1820 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
73410-003-01Fludeoxyglucose F 1830 mL in 1 VIAL, MULTI-DOSEINJECTION305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73410-003FLUDEOXYGLUCOSE F 18 INJECTION [SOFIE CO. DBA SOFIE]5Current NDC, Legacy NDC, 1 package rows20250501_915b1f71-616d-4cd9-90a7-bc556736a3d1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73410-003-017341000030130 mL in 1 VIAL, MULTI-DOSE (73410-003-01) 30 ml2019-11-060000-00-00NoNoCurrent