NDC 45567-0060

Kit for the Preparation of Technetium Tc99m Pyrophosphate

Technetium Tc99m Pyrophosphate

Kit for the Preparation of Technetium Tc99m Pyrophosphate is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Pharmalucence, Inc.. The primary component is Technetium Tc-99m Pyrophosphate.

Product ID45567-0060_19a054dd-f555-4547-93c8-1dd69e43dac6
NDC45567-0060
Product TypeHuman Prescription Drug
Proprietary NameKit for the Preparation of Technetium Tc99m Pyrophosphate
Generic NameTechnetium Tc99m Pyrophosphate
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date1987-06-30
Marketing CategoryNDA / NDA
Application NumberNDA019039
Labeler NamePharmalucence, Inc.
Substance NameTECHNETIUM TC-99M PYROPHOSPHATE
Active Ingredient Strength12 mg/10mL
Pharm ClassesRadioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 45567-0060-1

5 VIAL, MULTI-DOSE in 1 KIT (45567-0060-1) > 10 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date1987-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45567-0060-2 [45567006002]

Kit for the Preparation of Technetium Tc99m Pyrophosphate INJECTION
Marketing CategoryNDA
Application NumberNDA019039
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1987-06-30

NDC 45567-0060-1 [45567006001]

Kit for the Preparation of Technetium Tc99m Pyrophosphate INJECTION
Marketing CategoryNDA
Application NumberNDA019039
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1987-06-30

Drug Details

Active Ingredients

IngredientStrength
TECHNETIUM TC-99M PYROPHOSPHATE12 mg/10mL

OpenFDA Data

SPL SET ID:1f0cbd23-2fb3-43b7-b8af-7de246151149
Manufacturer
UNII

Pharmacological Class

  • Radioactive Diagnostic Agent [EPC]
  • Radiopharmaceutical Activity [MoA]

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.