FLUDEOXYGLUCOSE F 18
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 For intravenous use Initial U.S. Approval: 2005
Approved
Approval ID
4842b836-1a7c-4417-ab8d-aa37bf7065f8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 9, 2022
Manufacturers
FDA
UIHC-P E T IMAGING CENTER
DUNS: 063513265
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 Code24417-001
Application NumberANDA203990
Product Classification
M
Marketing Category
C73584
G
Generic Name
FLUDEOXYGLUCOSE F-18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 9, 2022
FDA Product Classification
INGREDIENTS (3)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
FLUDEOXYGLUCOSE F-18Active
Quantity: 300 mCi in 1 mL
Code: 0Z5B2CJX4D
Classification: ACTIB
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT