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
Approved
Approval ID
35bfa064-4313-49e2-98d2-85a84d2c40a4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 12, 2023
Manufacturers
FDA
The Regents of the University of Michigan
DUNS: 073133571
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fludeoxyglucose F18
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76326-001
Application NumberANDA204531
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fludeoxyglucose F18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 12, 2023
FDA Product Classification
INGREDIENTS (1)
FLUDEOXYGLUCOSE F-18Active
Quantity: 300 mCi in 1 mL
Code: 0Z5B2CJX4D
Classification: ACTIB