Kit for the Preparation of Technetium Tc99m Sestamibi
These highlights do not include all the information needed to use Kit for the Preparation of Technetium Tc 99m Sestamibi Injection safely and effectively. See full prescribing information for Kit for the Preparation of Technetium Tc 99m Sestamibi Injection. Kit for the Preparation of Technetium Tc 99m Sestamibi InjectionInitial U.S. Approval: 1990
Approved
Approval ID
8626e756-767a-4a14-9188-658b58185254
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 20, 2022
Manufacturers
FDA
Cardinal Health 414, LLC
DUNS: 069410546
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Kit for the Preparation of Technetium Tc99m Sestamibi
PRODUCT DETAILS
NDC Product Code65857-500
Application NumberANDA078809
Marketing CategoryC73584
Route of AdministrationPARENTERAL
Effective DateNovember 16, 2017
Generic NameKit for the Preparation of Technetium Tc99m Sestamibi
INGREDIENTS (5)
STANNOUS CHLORIDEInactive
Code: 1BQV3749L5
Classification: IACT
TECHNETIUM TC-99M SESTAMIBIActive
Quantity: 1 mg in 5 mL
Code: 971Z4W1S09
Classification: ACTIB
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
CYSTEINE HYDROCHLORIDEInactive
Code: ZT934N0X4W
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT