Cardiolite
These highlights do not include all the information needed to use CARDIOLITE safely and effectively. See full prescribing information for CARDIOLITE. CARDIOLITE®, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection Initial U.S. Approval: December, 1990
Approved
Approval ID
49662def-2fb9-47b2-8467-ca56f6006167
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 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 Code11994-001
Application NumberNDA019785
Product Classification
M
Marketing Category
C73594
G
Generic Name
TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 6, 2022
FDA Product Classification
INGREDIENTS (5)
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
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 2.6 mg in 1 mL
Code: B22547B95K
Classification: IACT
CYSTEINE HYDROCHLORIDEInactive
Quantity: 1 mg in 1 mL
Code: ZT934N0X4W
Classification: IACT