NDC 45567-0475

Kit for the Preparation of Technetium Tc99m Disofenin

Hepatolite

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

Product ID45567-0475_9466e179-86ab-47e0-b5cf-d73d66624efe
NDC45567-0475
Product TypeHuman Prescription Drug
Proprietary NameKit for the Preparation of Technetium Tc99m Disofenin
Generic NameHepatolite
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date1982-03-16
Marketing CategoryNDA / NDA
Application NumberNDA018467
Labeler NamePharmalucence, Inc.
Substance NameTECHNETIUM TC-99M DISOFENIN
Active Ingredient Strength20 mg/10mL
Pharm ClassesRadioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 45567-0475-1

5 VIAL in 1 KIT (45567-0475-1) > 10 mL in 1 VIAL
Marketing Start Date1982-03-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45567-0475-2 [45567047502]

Kit for the Preparation of Technetium Tc99m Disofenin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA018467
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1982-03-16
Marketing End Date2019-09-30

NDC 45567-0475-1 [45567047501]

Kit for the Preparation of Technetium Tc99m Disofenin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA018467
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1982-03-16
Marketing End Date2019-09-30

Drug Details

Active Ingredients

IngredientStrength
TECHNETIUM TC-99M DISOFENIN20 mg/10mL

OpenFDA Data

SPL SET ID:32c493f8-c4fa-4564-911b-ca2e1146c754
Manufacturer
UNII

Pharmacological Class

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

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