Fludeoxyglucose
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 Initial U.S. Approval: 2005
Approved
Approval ID
1751a998-6424-4f0e-8d45-ef96ad9f5f9a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 8, 2020
Manufacturers
FDA
SOFIE Co. dba SOFIE
DUNS: 957704737
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 Code49609-001
Application NumberANDA203665
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fludeoxyglucose F18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 8, 2020
FDA Product Classification
INGREDIENTS (1)
FLUDEOXYGLUCOSE F-18Active
Quantity: 500 mCi in 1 mL
Code: 0Z5B2CJX4D
Classification: ACTIB