Fludeoxyglucose F 18
These highlights do not include all the information needed to use FLUDEOXYGLUCOSE F 18 INJECTION, USP INJECTION 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
5d05df4a-463e-4e66-9387-f3a842e20cd0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
Jubilant DraxImage Inc., dba Jubilant Radiopharma
DUNS: 118310678
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 Code60055-334
Application NumberANDA203920
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fludeoxyglucose F-18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 12, 2017
FDA Product Classification
INGREDIENTS (4)
Fludeoxyglucose F-18Active
Quantity: 300 mCi in 1 mL
Code: 0Z5B2CJX4D
Classification: ACTIB
Sodium CitrateInactive
Code: 1Q73Q2JULR
Classification: IACT
Sodium ChlorideInactive
Quantity: 4.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
AlcoholInactive
Code: 3K9958V90M
Classification: IACT