Kit for the Preparation of Technetium Tc99m Sestamibi

Product NDC
45567-0555
11-digit product format
455670555
Labeler code
45567
Product ID
45567-0555_da951b14-fe9d-492c-950f-8a17e44dab31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TECHNETIUM TC-99M SESTAMIBI
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA079157
Marketing category
ANDA
Marketing start
2009-07-10
Marketing end
0000-00-00
Substance
TECHNETIUM TC-99M SESTAMIBI
Active strength
1 mg/10mL
Pharmacologic classes
Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45567-0555-1EA - Each45567-05555fb79dcc-463c-415c-84f9-008580b58e4f12015-10-02
45567-0555-2EA - Each45567-05559c296b70-f093-4a4a-a927-d2785fd4524512015-10-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45567-0555KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI (TECHNETIUM TC-99M SESTAMIBI) INJECTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]11Legacy NDC20240912_e545ac6a-83dc-485a-8bb4-c0b9d8f3d144.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45567-0555-1455670555015 VIAL in 1 CARTON (45567-0555-1) > 10 mL in 1 VIAL5 vial2009-07-100000-00-00NoNoCurrent
45567-0555-24556705550230 VIAL in 1 CARTON (45567-0555-2) > 10 mL in 1 VIAL30 vial2009-07-100000-00-00NoNoCurrent