Fludeoxyglucose F18
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: 2005
Approved
Approval ID
96398ed5-ffb9-4ed4-92c1-6a9535864475
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2012
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 Code13267-123
Application NumberNDA021870
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fludeoxyglucose F18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 18, 2012
FDA Product Classification
INGREDIENTS (1)
FLUDEOXYGLUCOSE F-18Active
Quantity: 300 mCi in 1 mL
Code: 0Z5B2CJX4D
Classification: ACTIB