NDC 65857-500

Kit for the Preparation of Technetium Tc99m Sestamibi

Kit For The Preparation Of Technetium Tc99m Sestamibi

Kit for the Preparation of Technetium Tc99m Sestamibi is a Parenteral Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Cardinal Health 414, Llc. The primary component is Technetium Tc-99m Sestamibi.

• Product ID: 65857-500_35798f1e-0853-4716-b42e-510c6e8003bd
• NDC: 65857-500
• Product Type: Human Prescription Drug
• Proprietary Name: Kit for the Preparation of Technetium Tc99m Sestamibi
• Generic Name: Kit For The Preparation Of Technetium Tc99m Sestamibi
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: PARENTERAL
• Marketing Start Date: 2010-06-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078809
• Labeler Name: Cardinal Health 414, LLC
• Substance Name: TECHNETIUM TC-99M SESTAMIBI
• Active Ingredient Strength: 1 mg/5mL
• Pharm Classes: Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 65857-500-20

20 VIAL in 1 CARTON (65857-500-20) > 5 mL in 1 VIAL

• Marketing Start Date: 2010-06-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65857-500-20 [65857050020]

Kit for the Preparation of Technetium Tc99m Sestamibi INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA078809
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-06-01

NDC 65857-500-05 [65857050005]

Kit for the Preparation of Technetium Tc99m Sestamibi INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA078809
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-06-01
• Marketing End Date: 2017-11-15

Drug Details

Active Ingredients

Ingredient	Strength
TECHNETIUM TC-99M SESTAMIBI	1 mg/5mL

OpenFDA Data

• SPL SET ID: 8626e756-767a-4a14-9188-658b58185254
• Manufacturer:
  • Cardinal Health 414, LLC
• UNII:
  • 971Z4W1S09

Pharmacological Class

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

NDC Crossover Matching brand name "Kit for the Preparation of Technetium Tc99m Sestamibi" or generic name "Kit For The Preparation Of Technetium Tc99m Sestamibi"

NDC	Brand Name	Generic Name
11994-003	Kit for the Preparation of Technetium Tc99m Sestamibi	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE
45567-0555	Kit for the Preparation of Technetium Tc99m Sestamibi	TECHNETIUM TC-99M SESTAMIBI
65857-500	Kit for the Preparation of Technetium Tc99m Sestamibi	Kit for the Preparation of Technetium Tc99m Sestamibi