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. Initial U.S. Approval 10/2014
Approved
Approval ID
84f1aeab-685d-47fd-a8e9-e724979c4ce6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 15, 2021
Manufacturers
FDA
Trustees of the University of Pennsylvania
DUNS: 042250712
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 Code40098-101
Application NumberANDA203801
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fludeoxyglucose F-18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 15, 2021
FDA Product Classification
INGREDIENTS (3)
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
FLUDEOXYGLUCOSE F-18Active
Quantity: 200 mCi in 1 mL
Code: 0Z5B2CJX4D
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT