FDA.reportPublic FDA data

Sodium Fluoride F 18

Product NDC
40028-512
11-digit product format
400280512
Labeler code
40028
Product ID
40028-512_53cdbece-6719-47f1-8bc0-da2d326f5802
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride F 18
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
PETNET Solutions, Inc.
Application
ANDA203890
Marketing category
ANDA
Marketing start
2011-01-26
Substance
SODIUM FLUORIDE 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
Sodium Fluoride F 18
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE F-18200 mCi/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9L75099X6R

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d79dac3-9c48-45b0-a9b7-a8ef22ff9f55Product name120151112
9209e30a-83c7-4466-acf0-7533654a2b1cProduct name920151029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40028-512-302021-04-20C16284748780-1ba0f9c33-5135-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use Sodium Fluoride F 18 Injection safely and effectively. See full prescribing information for Sodium Fluoride F 18 Injection. SODIUM FLUORIDE F 18 INJECTION For Intravenous Use Initial U.S. Approval: January 2011
40028-512-302021-04-20C16284748780-1ba0f9c33-5135-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use Sodium Fluoride F 18 Injection safely and effectively. See full prescribing information for Sodium Fluoride F 18 Injection. SODIUM FLUORIDE F 18 INJECTION For Intravenous Use Initial U.S. Approval: January 2011
40028-512-302021-01-29C16284748780-1ba0f9c33-5135-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use Sodium Fluoride F 18 Injection safely and effectively. See full prescribing information for Sodium Fluoride F 18 Injection. SODIUM FLUORIDE F 18 INJECTION For Intravenous Use Initial U.S. Approval: January 2011
40028-512-302021-01-29C16284748780-1ba0f9c33-5135-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use Sodium Fluoride F 18 Injection safely and effectively. See full prescribing information for Sodium Fluoride F 18 Injection. SODIUM FLUORIDE F 18 INJECTION For Intravenous Use Initial U.S. Approval: January 2011

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40028-512-30Sodium Fluoride F 1830 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION3015
40028-512-30Sodium Fluoride F 181 in 1 CANINJECTION, SOLUTION115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
40028-512-30EA - Each40028-512bf607692-86e7-479b-9ca8-4441b7aba9e412020-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDE F-18ACTIVE INGREDIENT9L75099X6RSODIUM FLUORIDE F 18 INJECTION, SOLUTION [PETNET SOLUTIONS, INC.]4
FLUORIDE ION F-18ACTIVE MOIETY4M4WE5N2GESODIUM FLUORIDE F 18 INJECTION, SOLUTION [PETNET SOLUTIONS, INC.]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSODIUM FLUORIDE F 18 INJECTION, SOLUTION [PETNET SOLUTIONS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40028-512SODIUM FLUORIDE F 18 INJECTION, SOLUTION [PETNET SOLUTIONS, INC.]11Current NDC, Legacy NDC, 2 package rows20241030_9a186741-f26c-4261-b1cb-25495497c7a2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
40028-512-30400280512301 VIAL, MULTI-DOSE in 1 CAN (40028-512-30) / 30 mL in 1 VIAL, MULTI-DOSE2011-01-260000-00-00NoNoCurrent