Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Kreitchman PET Center
Kreitchman PET Center
010861487
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fludeoxyglucose F18
Product Details
NDC Product Code
62072-008Application Number
ANDA203942Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
January 22, 2020SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
Fludeoxyglucose (18F)Active
Code: 0Z5B2CJX4DClass: ACTIBQuantity: 100 mCi in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 4.5 mg in 1 mL