DaTscan
These highlights do not include all the information needed to use DATSCAN safely and effectively. See full prescribing information for DATSCAN. DATSCAN (ioflupane I 123 injection), for intravenous use Initial U.S. Approval: 2011
Approved
Approval ID
ef7804d7-c691-495b-8aaf-5bc54fd5d9f6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
Medi-Physics Inc. dba GE Healthcare.
DUNS: 095263729
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ioflupane I-123
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17156-210
Application NumberNDA022454
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ioflupane I-123
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 9, 2022
FDA Product Classification
INGREDIENTS (4)
ioflupane I-123Active
Quantity: 2 mCi in 1 mL
Code: 3MM99T8R5Q
Classification: ACTIB
acetic acidInactive
Quantity: 5.8 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
sodium acetateInactive
Quantity: 8.2 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
alcoholInactive
Quantity: 0.05 mg in 1 mL
Code: 3K9958V90M
Classification: IACT