Fludeoxyglucose
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 USP, for intravenous use Initial U.S. Approval: 2005
Approved
Approval ID
1deaaa92-1c98-4295-8aa6-7a70bc29f55d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2023
Manufacturers
FDA
Biomedical Research Foundation of Northwest Louisiana
DUNS: 184750008
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 Code24562-001
Application NumberANDA203710
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fludeoxyglucose F-18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 8, 2021
FDA Product Classification
INGREDIENTS (3)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
Fludeoxyglucose F-18Active
Quantity: 300 mCi in 1 mL
Code: 0Z5B2CJX4D
Classification: ACTIB
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT