Neuraceq
These highlights do not include all the information needed to use NEURACEQ safely and effectively. See full prescribing information for NEURACEQ. NEURACEQ (florbetaben F 18 injection), for intravenous use Initial U.S. Approval: 2014
Approved
Approval ID
b0915068-cfd4-4d72-b9f8-7e31fe83cd1e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2024
Manufacturers
FDA
Life Molecular Imaging, Ltd
DUNS: 735628575
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
florbetaben F 18
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54828-001
Application NumberNDA204677
Product Classification
M
Marketing Category
C73594
G
Generic Name
florbetaben F 18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 13, 2022
FDA Product Classification
INGREDIENTS (6)
FLORBETABEN F-18Active
Quantity: 135 mCi in 1 mL
Code: TLA7312TOI
Classification: ACTIB
ALCOHOLInactive
Quantity: 118 mg in 1 mL
Code: 3K9958V90M
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Quantity: 200 mg in 1 mL
Code: B697894SGQ
Classification: IACT
SODIUM ASCORBATEInactive
Quantity: 28.8 mg in 1 mL
Code: S033EH8359
Classification: IACT
ASCORBIC ACIDInactive
Quantity: 4.4 mg in 1 mL
Code: PQ6CK8PD0R
Classification: IACT
WATERInactive
Quantity: 677.5 mg in 1 mL
Code: 059QF0KO0R
Classification: IACT