FDA.reportPublic FDA data

NDC 45567-0060-01 - Kit for the Preparation of Technetium Tc99m Pyrophosphate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
45567-0060
Requested NDC
45567-0060-01
Package NDCs from labels
45567-0060-1, 45567-0060-2, 45567-0060-01
Manufacturer
Sun Pharmaceutical Industries, Inc.
Effective date
2025-03-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
technetium tc99m pyrophosphate - Sun Pharmaceutical Industries, Inc.Sun Pharmaceutical Industries, Inc.2025-03-11HUMAN PRESCRIPTION DRUG LABEL

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 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

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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TECHNETIUM TC-99M PYROPHOSPHATEACTIVE INGREDIENT5L76I61H2BKIT FOR THE PREPARATION OF TECHNETIUM TC99M PYROPHOSPHATE (TECHNETIUM TC99M PYROPHOSPHATE) INJECTION [PHARMALUCENCE, INC.]3
TECHNETIUM TC-99M PYROPHOSPHATEACTIVE MOIETY5L76I61H2BKIT FOR THE PREPARATION OF TECHNETIUM TC99M PYROPHOSPHATE (TECHNETIUM TC99M PYROPHOSPHATE) INJECTION [PHARMALUCENCE, INC.]3
STANNOUS CHLORIDEINACTIVE INGREDIENT1BQV3749L5KIT FOR THE PREPARATION OF TECHNETIUM TC99M PYROPHOSPHATE (TECHNETIUM TC99M PYROPHOSPHATE) INJECTION [PHARMALUCENCE, INC.]3

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Technescan PYPTECHNETIUM TC 99M PYROPHOSPHATECurium US LLC304b63f4-a32e-4700-805d-5bc9f27e7d6a2025-12-05Warnings, Adverse reactionsExact identifier
unii: 1BQV3749L5
Kit for the Preparation of Technetium Tc99m PyrophosphateTECHNETIUM TC99M PYROPHOSPHATESun Pharmaceutical Industries, Inc.1f0cbd23-2fb3-43b7-b8af-7de2461511492025-03-11Warnings, Adverse reactionsExact identifier
application number: NDA019039
ndc (package): 45567-0060-1
ndc (package): 45567-0060-2
ndc (product): 45567-0060
ndc11 (package): 45567006001
spl id: 3010b45e-eed1-a5d0-e063-6294a90a40cf
spl set id: 1f0cbd23-2fb3-43b7-b8af-7de246151149
unii: 5L76I61H2B

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.