Sodium Fluoride
These 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: 2016
Approved
Approval ID
df1389d2-1b9b-4327-856e-5ba38118d389
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Kreitchman PET Center
DUNS: 010861487
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SODIUM FLUORIDE F-18
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62072-500
Application NumberANDA203936
Product Classification
M
Marketing Category
C73584
G
Generic Name
SODIUM FLUORIDE F-18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 24, 2016
FDA Product Classification
INGREDIENTS (2)
SODIUM FLUORIDE F-18Active
Quantity: 200 mCi in 1 mL
Code: 9L75099X6R
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT