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. FLUDEOXYGLUCOSE F18 INJECTION for intravenous use. Initial U.S. Approval: 2005
Approved
Approval ID
232fbb91-402e-44d8-a0cf-6813980b8ead
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 25, 2021
Manufacturers
FDA
Massachusetts General Hospital
DUNS: 156293698
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 Code76318-334
Application NumberANDA204333
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fludeoxyglucose F-18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 2, 2019
FDA Product Classification
INGREDIENTS (3)
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