Ioflupane I 123
These highlights do not include all the information needed to use IOFLUPANE I 123 INJECTION safely and effectively. See full prescribing information for IOFLUPANE I 123 INJECTION. IOFLUPANE I 123 injection, for intravenous use Initial U.S. Approval: 20 11
Approved
Approval ID
66d20aee-4530-48dd-a483-ed7604b36d97
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 16, 2022
Manufacturers
FDA
Curium US LLC
DUNS: 079875617
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
NDC Product Code69945-166
Application NumberANDA213792
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateDecember 27, 2022
Generic NameIOFLUPANE I-123
INGREDIENTS (4)
IOFLUPANE I-123Active
Quantity: 2 mCi in 1 mL
Code: 3MM99T8R5Q
Classification: ACTIB
SODIUM ACETATEInactive
Quantity: 7.8 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
ALCOHOLInactive
Quantity: 0.05 mL in 1 mL
Code: 3K9958V90M
Classification: IACT
ACETIC ACIDInactive
Quantity: 5.7 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT