FDA.reportPublic FDA data

TECHNETIUM TC 99M SESTAMIBI

Product NDC
45548-141
11-digit product format
455480141
Labeler code
45548
Product ID
45548-141_b089044e-6c93-4941-94e7-55786e5b57b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Technetium TC 99m Sestamibi
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Jubilant Draximage (USA) Inc.
Application
ANDA078806
Marketing category
ANDA
Marketing start
2009-07-01
Substance
TECHNETIUM TC-99M SESTAMIBI
Active strength
1 mg/mL
Pharmacologic classes
Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
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
TECHNETIUM TC-99M SESTAMIBI1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii971Z4W1S09

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
45548-141-05TECHNETIUM TC 99M SESTAMIBI5 in 1 KITINJECTION, POWDER, FOR SOLUTION514
45548-141-05TECHNETIUM TC 99M SESTAMIBI10 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION1014
45548-141-10TECHNETIUM TC 99M SESTAMIBI10 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION1014
45548-141-10TECHNETIUM TC 99M SESTAMIBI10 in 1 KITINJECTION, POWDER, FOR SOLUTION1014
45548-141-30TECHNETIUM TC 99M SESTAMIBI30 in 1 KITINJECTION, POWDER, FOR SOLUTION3014
45548-141-30TECHNETIUM TC 99M SESTAMIBI10 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION1014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45548-141-10EA - Each45548-1416620f928-b19f-4294-a7c3-98c5ca56ca4a12013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TECHNETIUM TC-99M SESTAMIBIACTIVE INGREDIENT971Z4W1S09KIT FOR THE PREPARATION OF TECHNETIUM TC 99M SESTAMIBI (TECHNETIUM TC 99M SESTAMIBI) INJECTION [DRAXIMAGE LLC]6
TECHNETIUM TC-99M SESTAMIBIACTIVE MOIETY971Z4W1S09KIT FOR THE PREPARATION OF TECHNETIUM TC 99M SESTAMIBI (TECHNETIUM TC 99M SESTAMIBI) INJECTION [DRAXIMAGE LLC]6
Cysteine HydrochlorideINACTIVE INGREDIENTZT934N0X4WKIT FOR THE PREPARATION OF TECHNETIUM TC 99M SESTAMIBI (TECHNETIUM TC 99M SESTAMIBI) INJECTION [DRAXIMAGE LLC]6
MannitolINACTIVE INGREDIENT3OWL53L36AKIT FOR THE PREPARATION OF TECHNETIUM TC 99M SESTAMIBI (TECHNETIUM TC 99M SESTAMIBI) INJECTION [DRAXIMAGE LLC]6
Stannous ChlorideINACTIVE INGREDIENT1BQV3749L5KIT FOR THE PREPARATION OF TECHNETIUM TC 99M SESTAMIBI (TECHNETIUM TC 99M SESTAMIBI) INJECTION [DRAXIMAGE LLC]6
Trisodium Citrate DihydrateINACTIVE INGREDIENTB22547B95KKIT FOR THE PREPARATION OF TECHNETIUM TC 99M SESTAMIBI (TECHNETIUM TC 99M SESTAMIBI) INJECTION [DRAXIMAGE LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45548-141TECHNETIUM TC 99M SESTAMIBI INJECTION, POWDER, FOR SOLUTION [JUBILANT DRAXIMAGE (USA) INC.]14Current NDC, Legacy NDC, 6 package rows20211023_07c893fc-cfba-1d98-0232-6448463afb87.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45548-141-05455480141055 VIAL in 1 KIT (45548-141-05) / 10 mL in 1 VIAL5 vial2009-07-010000-00-00NoNoCurrent
45548-141-104554801411010 VIAL in 1 KIT (45548-141-10) / 10 mL in 1 VIAL10 vial2009-07-010000-00-00NoNoCurrent
45548-141-304554801413030 VIAL in 1 KIT (45548-141-30) / 10 mL in 1 VIAL30 vial2009-07-010000-00-00NoNoCurrent