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:
Approved
Approval ID
ef58c3cd-a922-c5fc-e053-2a95a90a9d74
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2023
Manufacturers
FDA
BAMF Health Inc.
DUNS: 117208762
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 Code81759-002
Application NumberANDA204328
Product Classification
M
Marketing Category
C73584
G
Generic Name
SODIUM FLUORIDE F-18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 29, 2023
FDA Product Classification
INGREDIENTS (2)
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM FLUORIDE F-18Active
Quantity: 200 mCi in 1 mL
Code: 9L75099X6R
Classification: ACTIM