NDC 45567-0040

Kit for the Preparation of Technetium Tc 99M Medronate

Tc 99m Medronate

Kit for the Preparation of Technetium Tc 99M Medronate 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 Medronate.

• Product ID: 45567-0040_3c813eec-d4da-4c43-98ad-d2a218930093
• NDC: 45567-0040
• Product Type: Human Prescription Drug
• Proprietary Name: Kit for the Preparation of Technetium Tc 99M Medronate
• Generic Name: Tc 99m Medronate
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1979-08-29
• Marketing Category: NDA / NDA
• Application Number: NDA018124
• Labeler Name: Pharmalucence, Inc.
• Substance Name: TECHNETIUM TC-99M MEDRONATE
• Active Ingredient Strength: 20 mg/10mL
• Pharm Classes: Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 45567-0040-1

5 VIAL, MULTI-DOSE in 1 KIT (45567-0040-1) > 10 mL in 1 VIAL, MULTI-DOSE

• Marketing Start Date: 1979-08-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 45567-0040-1 [45567004001]

Kit for the Preparation of Technetium Tc 99M Medronate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA018124
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1979-08-29

NDC 45567-0040-2 [45567004002]

Kit for the Preparation of Technetium Tc 99M Medronate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA018124
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1979-08-29

Drug Details

Active Ingredients

Ingredient	Strength
TECHNETIUM TC-99M MEDRONATE	20 mg/10mL

OpenFDA Data

• SPL SET ID: 703d347c-e240-408a-b69d-9713e958a201
• Manufacturer:
  • Pharmalucence, Inc.
• UNII:
  • X89XV46R07

Pharmacological Class

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

NDC Crossover Matching brand name "Kit for the Preparation of Technetium Tc 99M Medronate" or generic name "Tc 99m Medronate"

NDC	Brand Name	Generic Name
45567-0040	Kit for the Preparation of Technetium Tc 99M Medronate	TC 99M MEDRONATE
65857-505	Kit for the Preparation of Technetium Tc 99m Medronate	technetium tc 99m medronate