FDA.reportPublic FDA data

Fludeoxyglucose F-18

Product NDC
52768-001
11-digit product format
527680001
Labeler code
52768
Product ID
52768-001_34048aac-62bc-4f71-8592-5d685e2a0da5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUDEOXYGLUCOSE F-18
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Precision Nuclear, LLC
Application
ANDA204546
Marketing category
ANDA
Marketing start
2010-10-10
Substance
FLUDEOXYGLUCOSE F-18
Active strength
500 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-18500 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
99a01b5c-59f4-409d-9148-0a2993e6f287Product name120150507
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52768-001-302021-08-03C16284748780-1ba0f9c33-4a9c-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use FLUDEOXYGLUCOSE F 18 INJECTION safely and effectively. See full prescribing information for FLUDEOXYGLUCOSE F 18 INJECTION. FLUDEOXYGLUCOSE F 18 INJECTION USP, for intravenous use Initial U.S. approval: 2005
52768-001-502021-08-03C16284748780-1ba0f9c33-4a9c-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use FLUDEOXYGLUCOSE F 18 INJECTION safely and effectively. See full prescribing information for FLUDEOXYGLUCOSE F 18 INJECTION. FLUDEOXYGLUCOSE F 18 INJECTION USP, for intravenous use Initial U.S. approval: 2005
52768-001-302021-01-29C16284748780-1ba0f9c33-4a9c-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use FLUDEOXYGLUCOSE F 18 INJECTION safely and effectively. See full prescribing information for FLUDEOXYGLUCOSE F 18 INJECTION. FLUDEOXYGLUCOSE F 18 INJECTION USP, for intravenous use Initial U.S. approval: 2005
52768-001-502021-01-29C16284748780-1ba0f9c33-4a9c-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use FLUDEOXYGLUCOSE F 18 INJECTION safely and effectively. See full prescribing information for FLUDEOXYGLUCOSE F 18 INJECTION. FLUDEOXYGLUCOSE F 18 INJECTION USP, for intravenous use Initial U.S. approval: 2005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52768-001-30Fludeoxyglucose F-181 in 1 CARTONINJECTION, SOLUTION19
52768-001-30Fludeoxyglucose F-1830 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION309
52768-001-50Fludeoxyglucose F-1850 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION509
52768-001-50Fludeoxyglucose F-181 in 1 CARTONINJECTION, SOLUTION19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUDEOXYGLUCOSE F-18ACTIVE INGREDIENT0Z5B2CJX4DFLUDEOXYGLUCOSE F-18 INJECTION, SOLUTION [PRECISION NUCLEAR LLC]5
FLUDEOXYGLUCOSE F-18ACTIVE MOIETY0Z5B2CJX4DFLUDEOXYGLUCOSE F-18 INJECTION, SOLUTION [PRECISION NUCLEAR LLC]5
ALCOHOLINACTIVE INGREDIENT3K9958V90MFLUDEOXYGLUCOSE F-18 INJECTION, SOLUTION [PRECISION NUCLEAR LLC]5
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPFLUDEOXYGLUCOSE F-18 INJECTION, SOLUTION [PRECISION NUCLEAR LLC]5
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFLUDEOXYGLUCOSE F-18 INJECTION, SOLUTION [PRECISION NUCLEAR LLC]5
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRFLUDEOXYGLUCOSE F-18 INJECTION, SOLUTION [PRECISION NUCLEAR LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52768-001FLUDEOXYGLUCOSE F-18 INJECTION, SOLUTION [PRECISION NUCLEAR, LLC]8Current NDC, Legacy NDC, 4 package rows20240331_09ae2a6d-673a-423a-ba45-3c543061b103.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52768-001-30527680001301 VIAL, MULTI-DOSE in 1 CARTON (52768-001-30) / 30 mL in 1 VIAL, MULTI-DOSE2010-10-100000-00-00NoNoCurrent
52768-001-50527680001501 VIAL, MULTI-DOSE in 1 CARTON (52768-001-50) / 50 mL in 1 VIAL, MULTI-DOSE2010-10-100000-00-00NoNoCurrent