Fludeoxyglucose F 18
These highlights do not include all the information needed to use FLUDEOXYGLUCOSE F 18 INJECTION USP safely and effectively. See full prescribing information for FLUDEOXYGLUCOSE F 18 INJECTION USP. FLUDEOXYGLUCOSE F 18 INJECTION USP for intravenous use Initial U.S. Approval: 2005
Approved
Approval ID
ae48ac7d-1c50-4b32-a3e6-c2e5de5b63ed
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 29, 2021
Manufacturers
FDA
Washington University School of Medicine
DUNS: 618078752
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 Code75913-647
Application NumberANDA203935
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fludeoxyglucose F 18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 29, 2021
FDA Product Classification
INGREDIENTS (4)
SODIUM CHLORIDEInactive
Quantity: 4.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
ALCOHOLInactive
Quantity: 5 mg in 1 mL
Code: 3K9958V90M
Classification: IACT
FLUDEOXYGLUCOSE F-18Active
Quantity: 300 mCi in 1 mL
Code: 0Z5B2CJX4D
Classification: ACTIB
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT