Manufacturing Establishments6
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
PharmaLogic Salt Lake City, LLC
Life Molecular Imaging, Ltd
119319723
PharmaLogic Colorado, LLC
Life Molecular Imaging, Ltd
117608150
SOFIE Co. dba SOFIE
Life Molecular Imaging, Ltd
008017970
Jubilant DraxImage Inc. dba Jubilant Radiopharma
Life Molecular Imaging, Ltd
080871701
PharmaLogic Cincinnati, LLC
Life Molecular Imaging, Ltd
118408248
N-Molecular, Inc. dba SOFIE
Life Molecular Imaging, Ltd
079932600
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Neuraceq
Product Details
NDC Product Code
54828-001Application Number
NDA204677Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
June 13, 2022Florbetaben F-18Active
Code: TLA7312TOIClass: ACTIBQuantity: 135 mCi in 1 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACTQuantity: 118 mg in 1 mL
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACTQuantity: 200 mg in 1 mL
SODIUM ASCORBATEInactive
Code: S033EH8359Class: IACTQuantity: 28.8 mg in 1 mL
ASCORBIC ACIDInactive
Code: PQ6CK8PD0RClass: IACTQuantity: 4.4 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACTQuantity: 677.5 mg in 1 mL