Kit for the Preparation of Technetium Tc99m Sestamibi
These highlights do not include all the information needed to use Technetium Tc99m Sestamibi safely and effectively. See full prescribing information for Technetium Tc99m Sestamibi. Kit for the Preparation of Technetium Tc99m Sestamibi for Injection Initial U.S. Approval: December, 1990
Approved
Approval ID
8c03a854-185a-45d7-883f-9f87e4750181
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 18, 2022
Manufacturers
FDA
Lantheus Medical Imaging, Inc.
DUNS: 176786812
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code11994-003
Application NumberNDA019785
Product Classification
M
Marketing Category
C73594
G
Generic Name
TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 18, 2022
FDA Product Classification
INGREDIENTS (5)
CYSTEINE HYDROCHLORIDEInactive
Quantity: 1 mg in 1 mL
Code: ZT934N0X4W
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 2.6 mg in 1 mL
Code: B22547B95K
Classification: IACT
TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATEActive
Quantity: 1 mg in 1 mL
Code: N6OU7HJ70P
Classification: ACTIB
MANNITOLInactive
Quantity: 20 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
STANNOUS CHLORIDEInactive
Quantity: 0.075 mg in 1 mL
Code: 1BQV3749L5
Classification: IACT