Sodium Fluoride
These highlights do not include all the information needed to use Sodium Fluoride F 18 Injection, USP safely and effectively. See full prescribing information for Sodium Fluoride F 18 Injection, USP. SODIUM FLUORIDE F 18 INJECTION, USPFor Intravenous UseInitial U.S. Approval: 2014
Approved
Approval ID
f8afb06c-f4c3-46f0-8f8b-0bc9e072ce47
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 11, 2019
Manufacturers
FDA
THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH
DUNS: 110565913
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 Code13267-542
Application NumberANDA204328
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sodium Fluoride F 18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 11, 2019
FDA Product Classification
INGREDIENTS (2)
SODIUM FLUORIDE F-18Active
Quantity: 600 mCi in 1 mL
Code: 9L75099X6R
Classification: ACTIM
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT