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TECHNETIUM TC 99M 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 Injection (tetrakis(1-isocyano-2-methoxy-2-methyl-propane)-copper(1) tetrafluoroborate) injection, powder, lyophilized, for solution forIntravenous use. Initial U.S. Approval: December 1990

Approved
Approval ID

07c893fc-cfba-1d98-0232-6448463afb87

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 22, 2021

Manufacturers
FDA

Jubilant Draximage (USA) Inc.

DUNS: 080981460

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 Code45548-141
Application NumberANDA078806
Product Classification
M
Marketing Category
C73584
G
Generic Name
Technetium TC 99m Sestamibi
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 13, 2017
FDA Product Classification

INGREDIENTS (5)

TECHNETIUM TC-99M SESTAMIBIActive
Quantity: 1 mg in 1 mL
Code: 971Z4W1S09
Classification: ACTIR
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 2.6 mg in 1 mL
Code: B22547B95K
Classification: IACT
Stannous ChlorideInactive
Quantity: 0.075 mg in 1 mL
Code: 1BQV3749L5
Classification: IACT
Cysteine HydrochlorideInactive
Quantity: 1 mg in 1 mL
Code: ZT934N0X4W
Classification: IACT
MannitolInactive
Quantity: 20 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT

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