FDA.reportPublic FDA data

Fludeoxyglucose F 18

Product NDC
40028-511
11-digit product format
400280511
Labeler code
40028
Product ID
40028-511_eae7ce3e-b6c1-4dee-81b2-d690ac938e35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fludeoxyglucose F 18
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
PETNET Solutions, Inc.
Application
ANDA079086
Marketing category
ANDA
Marketing start
2008-07-29
Substance
FLUDEOXYGLUCOSE F-18
Active strength
200 mCi/mL
Pharmacologic classes
Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fludeoxyglucose F 18
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUDEOXYGLUCOSE F-18200 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40028-511-302021-04-20C16284748780-1ba0f9c33-48a2-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use F ludeoxyglucose F 18 I njection safely and effectively. See full prescribing information for F ludeoxyglucose F 18 I njection. Fludeoxyglucose F 18 I njection , USP F or intravenous use Initial U.S. Approval: 2005
40028-511-302021-04-20C16284748780-1ba0f9c33-48a2-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use F ludeoxyglucose F 18 I njection safely and effectively. See full prescribing information for F ludeoxyglucose F 18 I njection. Fludeoxyglucose F 18 I njection , USP F or intravenous use Initial U.S. Approval: 2005
40028-511-502021-04-20C16284748780-1ba0f9c33-48a2-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use F ludeoxyglucose F 18 I njection safely and effectively. See full prescribing information for F ludeoxyglucose F 18 I njection. Fludeoxyglucose F 18 I njection , USP F or intravenous use Initial U.S. Approval: 2005
40028-511-502021-04-20C16284748780-1ba0f9c33-48a2-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use F ludeoxyglucose F 18 I njection safely and effectively. See full prescribing information for F ludeoxyglucose F 18 I njection. Fludeoxyglucose F 18 I njection , USP F or intravenous use Initial U.S. Approval: 2005
40028-511-302021-01-29C16284748780-1ba0f9c33-48a2-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use F ludeoxyglucose F 18 I njection safely and effectively. See full prescribing information for F ludeoxyglucose F 18 I njection. Fludeoxyglucose F 18 I njection , USP F or intravenous use Initial U.S. Approval: 2005
40028-511-302021-01-29C16284748780-1ba0f9c33-48a2-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use F ludeoxyglucose F 18 I njection safely and effectively. See full prescribing information for F ludeoxyglucose F 18 I njection. Fludeoxyglucose F 18 I njection , USP F or intravenous use Initial U.S. Approval: 2005
40028-511-502021-01-29C16284748780-1ba0f9c33-48a2-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use F ludeoxyglucose F 18 I njection safely and effectively. See full prescribing information for F ludeoxyglucose F 18 I njection. Fludeoxyglucose F 18 I njection , USP F or intravenous use Initial U.S. Approval: 2005
40028-511-502021-01-29C16284748780-1ba0f9c33-48a2-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use F ludeoxyglucose F 18 I njection safely and effectively. See full prescribing information for F ludeoxyglucose F 18 I njection. Fludeoxyglucose F 18 I njection , USP F or intravenous use Initial U.S. Approval: 2005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40028-511-50Fludeoxyglucose F 1850 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION5024
40028-511-50Fludeoxyglucose F 181 in 1 CANINJECTION, SOLUTION124
40028-511-99Fludeoxyglucose F 181 in 1 CANINJECTION, SOLUTION124
40028-511-99Fludeoxyglucose F 18100 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION10024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
40028-511-30EA - Each40028-511d7f8060c-9111-44a4-adc2-de388c30b54d12018-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUDEOXYGLUCOSE F-18ACTIVE INGREDIENT0Z5B2CJX4DFLUDEOXYGLUCOSE F 18 INJECTION, SOLUTION [PETNET SOLUTIONS, INC.]11
FLUDEOXYGLUCOSE F-18ACTIVE MOIETY0Z5B2CJX4DFLUDEOXYGLUCOSE F 18 INJECTION, SOLUTION [PETNET SOLUTIONS, INC.]11
ALCOHOLINACTIVE INGREDIENT3K9958V90MFLUDEOXYGLUCOSE F 18 INJECTION, SOLUTION [PETNET SOLUTIONS, INC.]11
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFLUDEOXYGLUCOSE F 18 INJECTION, SOLUTION [PETNET SOLUTIONS, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40028-511FLUDEOXYGLUCOSE F 18 INJECTION, SOLUTION [PETNET SOLUTIONS, INC.]20Current NDC, Legacy NDC, 4 package rows20241030_caaa9ab5-e3f4-489d-9f4c-0ecbee6fca83.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
40028-511-30400280511301 VIAL, MULTI-DOSE in 1 CAN (40028-511-30) > 30 mL in 1 VIAL, MULTI-DOSE2008-07-290000-00-00NoNoCurrent
40028-511-50400280511501 VIAL, MULTI-DOSE in 1 CAN (40028-511-50) / 50 mL in 1 VIAL, MULTI-DOSE2008-07-290000-00-00NoNoCurrent
40028-511-99400280511991 VIAL, MULTI-DOSE in 1 CAN (40028-511-99) / 100 mL in 1 VIAL, MULTI-DOSE2008-07-29NoNoCurrent