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: XXXX
Approved
Approval ID
2bbd8f48-fdf9-45cb-8305-124a03f7a52c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 8, 2018
Manufacturers
FDA
SOFIE Co.
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 Code49609-102
Application NumberANDA203592
Product Classification
M
Marketing Category
C73584
G
Generic Name
SODIUM FLUORIDE F-18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 8, 2018
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