Sodium Fluoride F 18
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: January 2011
Approved
Approval ID
4c45fe05-e3b7-4383-966c-4e218ff6f94a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 7, 2023
Manufacturers
FDA
Biomedical Research Foundation of Northwest Louisiana
DUNS: 184750008
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 Code24562-002
Application NumberANDA204351
Product Classification
M
Marketing Category
C73584
G
Generic Name
SODIUM FLUORIDE F-18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 14, 2015
FDA Product Classification
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