Fludeoxyglucose F-18
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, USPInitial U.S. Approval: 2005
Approved
Approval ID
08044d8f-036c-4809-997f-dd5180feebe6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 4, 2020
Manufacturers
FDA
Cardinal Health 414, LLC
DUNS: 069410546
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 Code65857-150
Application NumberANDA203603
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fludeoxyglucose F-18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 4, 2020
FDA Product Classification
INGREDIENTS (5)
FLUDEOXYGLUCOSE F-18Active
Quantity: 500 mCi in 1 mL
Code: 0Z5B2CJX4D
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DISODIUM CITRATE SESQUIHYDRATEInactive
Code: CZ1032CEKR
Classification: IACT