Fludeoxyglucose F18

Product NDC
69864-001
11-digit product format
698640001
Labeler code
69864
Product ID
69864-001_c961907a-db84-c6f2-e053-2995a90aefd2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fludeoxyglucose F18
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
The Methodist Hospital Research Institute
Application
ANDA203904
Marketing category
ANDA
Marketing start
2012-04-23
Substance
FLUDEOXYGLUCOSE F-18
Active strength
.3 Ci/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 F18
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUDEOXYGLUCOSE F-18.3 Ci/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
69864-001-30Fludeoxyglucose F1830 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69864-001FLUDEOXYGLUCOSE F18 INJECTION, SOLUTION [THE METHODIST HOSPITAL RESEARCH INSTITUTE]3Current NDC, Legacy NDC, 1 package rows20210817_195d1b07-5669-247f-e054-00144ff8d46c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69864-001-306986400013030 mL in 1 VIAL, MULTI-DOSE (69864-001-30) 30 ml2012-04-230000-00-00NoNoCurrent