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. FLUDEOXYGLUCOSEF 18 INJECTION, USP, for intravenous useInitial U.S. Approval: 2005
Approved
Approval ID
2028be0c-333c-4e0c-be57-099276c725d7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 14, 2021
Manufacturers
FDA
SOFIE Co.
DUNS: 957704737
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 Code49609-101
Application NumberANDA203591
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fludeoxyglucose F-18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 14, 2021
FDA Product Classification
INGREDIENTS (4)
Sodium ChlorideInactive
Quantity: 4.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
AlcoholInactive
Quantity: 5 mg in 1 mL
Code: 3K9958V90M
Classification: IACT
Fludeoxyglucose F-18Active
Quantity: 300 mCi in 1 mL
Code: 0Z5B2CJX4D
Classification: ACTIB
Sodium Citrate, Unspecified FormInactive
Quantity: 7.2 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT