Fludeoxyglucose F 18
These highlights do not include all the information needed to use F ludeoxyglucose F 18 I njection safely and effectively. See full prescribing information for F ludeoxyglucose F 18 I njection. Fludeoxyglucose F 18 I njection , USP F or intravenous use Initial U.S. Approval: 2005
Approved
Approval ID
caaa9ab5-e3f4-489d-9f4c-0ecbee6fca83
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2019
Manufacturers
FDA
PETNET Solutions, Inc.
DUNS: 015223951
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 Code40028-511
Application NumberANDA079086
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fludeoxyglucose F 18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 9, 2023
FDA Product Classification
INGREDIENTS (3)
FLUDEOXYGLUCOSE F-18Active
Quantity: 200 mCi in 1 mL
Code: 0Z5B2CJX4D
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 4.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
ALCOHOLInactive
Quantity: 5 mg in 1 mL
Code: 3K9958V90M
Classification: IACT