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: 2011
Approved
Approval ID
d867a881-108e-41fa-91ab-dc4df00cbb55
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 7, 2020
Manufacturers
FDA
SOFIE Co. dba SOFIE
DUNS: 957704737
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 Code49609-002
Application NumberANDA203544
Product Classification
M
Marketing Category
C73584
G
Generic Name
SODIUM FLUORIDE F-18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 7, 2020
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