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 USP For Intravenous Use Initial U.S. Approval: xxxx
Approved
Approval ID
e435568c-f8d2-4cee-aceb-c68b277ad8f5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 4, 2023
Manufacturers
FDA
Mayo Clinic
DUNS: 167141923
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 Code52670-550
Application NumberANDA203605
Product Classification
M
Marketing Category
C73584
G
Generic Name
sodium fluoride F 18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 4, 2023
FDA Product Classification
INGREDIENTS (2)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM FLUORIDE F-18Active
Quantity: 91.5 mCi in 1 mL
Code: 9L75099X6R
Classification: ACTIM