Technetium Tc 99m Sestamibi
These highlights do not include all the information needed to use Kit for the Preparation of Technetium Tc99m Sestamibi Injection safely and effectively. See full prescribing information for Kit for the Preparation of Technetium Tc99m Sestamibi Injection. Kit for the Preparation of Technetium Tc99m Sestamibi Injection Initial U.S. Approval: December, 1990
Approved
Approval ID
4110d0f4-3bcf-4688-a39f-42a81064c796
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 19, 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.
Technetium Tc 99m Sestamibi
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69945-092
Application NumberANDA078098
Product Classification
M
Marketing Category
C73584
G
Generic Name
Technetium Tc 99m Sestamibi
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 7, 2021
FDA Product Classification
INGREDIENTS (5)
TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATEActive
Quantity: 1 mg in 1 mL
Code: N6OU7HJ70P
Classification: ACTIB
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
STANNOUS CHLORIDEInactive
Code: 1BQV3749L5
Classification: IACT
CYSTEINE HYDROCHLORIDEInactive
Code: ZT934N0X4W
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT