NDC 45567-0555

Kit for the Preparation of Technetium Tc99m Sestamibi

Technetium Tc-99m Sestamibi

Kit for the Preparation of Technetium Tc99m Sestamibi 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 Sestamibi.

• Product ID: 45567-0555_192938db-689e-4b94-9bf1-e93d5052bc53
• NDC: 45567-0555
• Product Type: Human Prescription Drug
• Proprietary Name: Kit for the Preparation of Technetium Tc99m Sestamibi
• Generic Name: Technetium Tc-99m Sestamibi
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2009-07-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA079157
• Labeler Name: Pharmalucence, Inc.
• Substance Name: TECHNETIUM TC-99M SESTAMIBI
• Active Ingredient Strength: 1 mg/10mL
• Pharm Classes: Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 45567-0555-1

5 VIAL in 1 CARTON (45567-0555-1) > 10 mL in 1 VIAL

• Marketing Start Date: 2009-07-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 45567-0555-1 [45567055501]

Kit for the Preparation of Technetium Tc99m Sestamibi INJECTION

• Marketing Category: ANDA
• Application Number: ANDA079157
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-07-10

NDC 45567-0555-2 [45567055502]

Kit for the Preparation of Technetium Tc99m Sestamibi INJECTION

• Marketing Category: ANDA
• Application Number: ANDA079157
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-07-10

Drug Details

Active Ingredients

Ingredient	Strength
TECHNETIUM TC-99M SESTAMIBI	1 mg/10mL

OpenFDA Data

• SPL SET ID: e545ac6a-83dc-485a-8bb4-c0b9d8f3d144
• Manufacturer:
  • Pharmalucence, Inc.
• UNII:
  • 971Z4W1S09

Pharmacological Class

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

NDC Crossover Matching brand name "Kit for the Preparation of Technetium Tc99m Sestamibi" or generic name "Technetium Tc-99m 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