Fludeoxyglucose F 18
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: 1994
Approved
Approval ID
982b9df4-0772-4de1-a01e-794a77518500
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 5, 2023
Manufacturers
FDA
Kettering Medical Center
DUNS: 071288450
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 Code29998-001
Application NumberANDA204759
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fludeoxyglucose F-18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 27, 2015
FDA Product Classification
INGREDIENTS (2)
Fludeoxyglucose F-18Active
Quantity: 40 mCi in 1 mL
Code: 0Z5B2CJX4D
Classification: ACTIB
Sodium ChlorideInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT