Fludeoxyglucose F18
These highlights do not include all the information needed to use Fludeoxyglucose F 18 Injection safely and effectively. See full prescribing information for Fludeoxyglucose F 18 Injection. Fludeoxyglucose F 18 Injection, for intravenous use. Initial U.S. Approval: 2005
Approved
Approval ID
763958a2-6952-4c0d-8a4a-9c04acb62229
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 8, 2023
Manufacturers
FDA
UCSF Radiopharmaceutical Facility
DUNS: 831727388
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 Code24275-0185
Application NumberANDA203902
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fludeoxyglucose F18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 8, 2023
FDA Product Classification
INGREDIENTS (1)
FLUDEOXYGLUCOSE F-18Active
Quantity: 300 mCi in 1 mL
Code: 0Z5B2CJX4D
Classification: ACTIB