Fludeoxyglucose
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 useInitial U.S. Approval: 2005
Approved
Approval ID
dfd91498-4bfc-4d45-a9a3-cee6153ae573
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 11, 2019
Manufacturers
FDA
THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
DUNS: 110565913
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 Code13267-234
Application NumberNDA021870
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fludeoxyglucose F18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 12, 2019
FDA Product Classification
INGREDIENTS (1)
FLUDEOXYGLUCOSE F-18Active
Quantity: 400 mCi in 1 mL
Code: 0Z5B2CJX4D
Classification: ACTIB