Fludeoxyglucose F 18
These highlights do not include all the information needed to use Fludeoxyglucose F 18 Injection USP safely and effectively. See full prescribing information for Fludeoxyglucose F 18 Injection USP . Fludeoxyglucose F 18 Injection USP Initial U.S. Approval: 2005
Approved
Approval ID
153b650d-7b69-4880-a72a-a5f13059d248
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.
Fludeoxyglucose F-18
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52670-551
Application NumberANDA203612
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fludeoxyglucose F-18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 4, 2023
FDA Product Classification
INGREDIENTS (2)
SODIUM CHLORIDEInactive
Quantity: 4.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
FLUDEOXYGLUCOSE F-18Active
Quantity: 240 mCi in 1 mL
Code: 0Z5B2CJX4D
Classification: ACTIB