Technetium Tc 99m Sestamibi

Product NDC
69945-092
11-digit product format
699450092
Labeler code
69945
Product ID
69945-092_4b00526c-6250-49d7-ba34-459ef89c8f43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Technetium Tc 99m Sestamibi
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Curium US LLC
Application
ANDA078098
Marketing category
ANDA
Marketing start
2011-10-31
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
Technetium Tc 99m Sestamibi
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN6OU7HJ70P

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69945-092-20Technetium Tc 99m Sestamibi5 in 1 CELLO PACKINJECTION515
69945-092-20Technetium Tc 99m Sestamibi10 mL in 1 VIALINJECTION1015
69945-092-40Technetium Tc 99m Sestamibi30 in 1 CARTONINJECTION3015
69945-092-40Technetium Tc 99m Sestamibi10 mL in 1 VIALINJECTION1015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69945-092-20EA - Each69945-092937063fc-38d4-46f9-8884-28900d1d5f8712019-06-19
69945-092-40EA - Each69945-092a142536d-9824-47fe-a9e2-44a25281e40c12019-06-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATEACTIVE INGREDIENTN6OU7HJ70PTECHNETIUM TC 99M SESTAMIBI INJECTION [MALLINCKRODT NUCLEAR MEDICINE LLC]2
TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATEACTIVE MOIETYN6OU7HJ70PTECHNETIUM TC 99M SESTAMIBI INJECTION [MALLINCKRODT NUCLEAR MEDICINE LLC]2
CYSTEINE HYDROCHLORIDEINACTIVE INGREDIENTZT934N0X4WTECHNETIUM TC 99M SESTAMIBI INJECTION [MALLINCKRODT NUCLEAR MEDICINE LLC]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ATECHNETIUM TC 99M SESTAMIBI INJECTION [MALLINCKRODT NUCLEAR MEDICINE LLC]2
STANNOUS CHLORIDEINACTIVE INGREDIENT1BQV3749L5TECHNETIUM TC 99M SESTAMIBI INJECTION [MALLINCKRODT NUCLEAR MEDICINE LLC]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KTECHNETIUM TC 99M SESTAMIBI INJECTION [MALLINCKRODT NUCLEAR MEDICINE LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69945-092TECHNETIUM TC 99M SESTAMIBI INJECTION [CURIUM US LLC]15Current NDC, Legacy NDC, 4 package rows20220528_4110d0f4-3bcf-4688-a39f-42a81064c796.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69945-092-20699450092205 VIAL in 1 CELLO PACK (69945-092-20) / 10 mL in 1 VIAL5 vial2011-10-310000-00-00NoNoCurrent
69945-092-406994500924030 VIAL in 1 CARTON (69945-092-40) / 10 mL in 1 VIAL30 vial2011-10-310000-00-00NoNoCurrent