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 for Injection safely and effectively. See full prescribing information for Kit for the Preparation of Technetium Tc 99m Sestamibi for Injection. Kit for the Preparation of Technetium Tc 99m Sestamibi for Injection Kit for intravenous use Initial U.S. Approval: 1990
Approved
Approval ID
e545ac6a-83dc-485a-8bb4-c0b9d8f3d144
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 31, 2020
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 139261648
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 Code45567-0555
Application NumberANDA079157
Product Classification
M
Marketing Category
C73584
G
Generic Name
TECHNETIUM TC-99M SESTAMIBI
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 31, 2020
FDA Product Classification
INGREDIENTS (5)
CYSTEINE HYDROCHLORIDEInactive
Quantity: 1 mg in 10 mL
Code: ZT934N0X4W
Classification: IACT
TECHNETIUM TC-99M SESTAMIBIActive
Quantity: 1 mg in 10 mL
Code: 971Z4W1S09
Classification: ACTIB
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 2.6 mg in 10 mL
Code: B22547B95K
Classification: IACT
STANNOUS CHLORIDEInactive
Quantity: 0.075 mg in 10 mL
Code: 1BQV3749L5
Classification: IACT
MANNITOLInactive
Quantity: 20 mg in 10 mL
Code: 3OWL53L36A
Classification: IACT