Home NDC 11994-003 Kit for the Preparation of Technetium Tc99m Sestamibi
Product NDC 11994-003
11-digit product format 119940003
Labeler code 11994
Product ID 11994-003_517b7337-3529-4948-8d02-b8e2cf97a161
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Lantheus Medical Imaging, Inc.
Application NDA019785
Marketing category NDA
Marketing start 1990-12-20
Substance TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE
Active strength 1 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Kit for the Preparation of Technetium Tc99m Sestamibi
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE 1 mg/mL
Harmonized Identifiers# Field, Values table Field Values Unii N6OU7HJ70P
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11994-003-20 Kit for the Preparation of Technetium Tc99m Sestamibi 5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 5 5 11994-003-20 Kit for the Preparation of Technetium Tc99m Sestamibi 20 in 1 BOX INJECTION, POWDER, LYOPHILIZED, 20 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE ACTIVE INGREDIENT N6OU7HJ70P KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI (TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LANTHEUS MEDICAL IMAGING, INC.] 1 TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE ACTIVE MOIETY N6OU7HJ70P KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI (TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LANTHEUS MEDICAL IMAGING, INC.] 1 CYSTEINE HYDROCHLORIDE INACTIVE INGREDIENT ZT934N0X4W KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI (TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LANTHEUS MEDICAL IMAGING, INC.] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI (TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LANTHEUS MEDICAL IMAGING, INC.] 1 STANNOUS CHLORIDE INACTIVE INGREDIENT 1BQV3749L5 KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI (TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LANTHEUS MEDICAL IMAGING, INC.] 1 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI (TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LANTHEUS MEDICAL IMAGING, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11994-003 KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI (TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LANTHEUS MEDICAL IMAGING, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20221123_8c03a854-185a-45d7-883f-9f87e4750181.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 11994-003-20 11994000320 20 VIAL in 1 BOX (11994-003-20) / 5 mL in 1 VIAL 20 vial 1990-12-20 0000-00-00 No No Current