Sodium Fluoride F 18
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: January 2011
Approved
Approval ID
9a186741-f26c-4261-b1cb-25495497c7a2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2016
Manufacturers
FDA
PETNET Solutions, Inc.
DUNS: 015223951
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
NDC Product Code40028-512
Application NumberANDA203890
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateMarch 9, 2023
Generic NameSodium Fluoride F 18
INGREDIENTS (2)
SODIUM FLUORIDE F-18Active
Quantity: 200 mCi in 1 mL
Code: 9L75099X6R
Classification: ACTIM
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT