Kit for the Preparation of Technetium Tc99m Pyrophosphate

Product NDC
45567-0060
11-digit product format
455670060
Labeler code
45567
Product ID
45567-0060_3010b45e-eed1-a5d0-e063-6294a90a40cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
technetium tc99m pyrophosphate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA019039
Marketing category
NDA
Marketing start
1987-06-30
Substance
TECHNETIUM TC-99M PYROPHOSPHATE
Active strength
12 mg/10mL
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
Kit for the Preparation of Technetium Tc99m Pyrophosphate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TECHNETIUM TC-99M PYROPHOSPHATE12 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5L76I61H2B

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45567-0060-1Kit for the Preparation of Technetium Tc99m Pyrophosphate5 in 1 KITINJECTION59
45567-0060-1Kit for the Preparation of Technetium Tc99m Pyrophosphate10 mL in 1 VIAL, MULTI-DOSEINJECTION109
45567-0060-2Kit for the Preparation of Technetium Tc99m Pyrophosphate30 in 1 KITINJECTION309
45567-0060-2Kit for the Preparation of Technetium Tc99m Pyrophosphate10 mL in 1 VIAL, MULTI-DOSEINJECTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45567-0060-1EA - Each45567-0060ef0ca910-d165-4286-81ee-7f3353bb03c012015-10-02
45567-0060-2EA - Each45567-00602d744ce6-3b83-482e-a4bd-0d8946baef6612015-10-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45567-0060KIT FOR THE PREPARATION OF TECHNETIUM TC99M PYROPHOSPHATE (TECHNETIUM TC99M PYROPHOSPHATE) INJECTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]9Current NDC, Legacy NDC, 4 package rows20250412_1f0cbd23-2fb3-43b7-b8af-7de246151149.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45567-0060-1455670060015 VIAL, MULTI-DOSE in 1 KIT (45567-0060-1) / 10 mL in 1 VIAL, MULTI-DOSE1987-06-300000-00-00NoNoCurrent
45567-0060-24556700600230 VIAL, MULTI-DOSE in 1 KIT (45567-0060-2) / 10 mL in 1 VIAL, MULTI-DOSE1987-06-300000-00-00NoNoCurrent