Fludeoxyglucose
These highlights do not include all the information needed to use Fludeoxyglucose F18 Injection safely and effectively. See full prescribing information for Fludeoxyglucose F18 Injection. Fludeoxyglucose F18 Injection Initial U.S. Approval: 2016
Approved
Approval ID
1e415eb3-e8a5-4149-b4ec-ba9ab3b29d7f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Kreitchman PET Center
DUNS: 010861487
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fludeoxyglucose F18
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62072-008
Application NumberANDA203942
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fludeoxyglucose F18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 22, 2020
FDA Product Classification
INGREDIENTS (3)
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
FLUDEOXYGLUCOSE F-18Active
Quantity: 100 mCi in 1 mL
Code: 0Z5B2CJX4D
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 4.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT