NDC 45548-141

TECHNETIUM TC 99M SESTAMIBI

Technetium Tc 99m Sestamibi

TECHNETIUM TC 99M SESTAMIBI is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Jubilant Draximage (usa) Inc.. The primary component is Technetium Tc-99m Sestamibi.

• Product ID: 45548-141_04fe3660-2df7-4a7b-b1b3-49270fb459a4
• NDC: 45548-141
• Product Type: Human Prescription Drug
• Proprietary Name: TECHNETIUM TC 99M SESTAMIBI
• Generic Name: Technetium Tc 99m Sestamibi
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2009-07-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078806
• Labeler Name: Jubilant Draximage (USA) Inc.
• Substance Name: TECHNETIUM TC-99M SESTAMIBI
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 45548-141-05

5 VIAL in 1 KIT (45548-141-05) > 10 mL in 1 VIAL

• Marketing Start Date: 2009-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 45548-141-05 [45548014105]

TECHNETIUM TC 99M SESTAMIBI INJECTION, POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA078806
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-07-01

NDC 45548-141-10 [45548014110]

TECHNETIUM TC 99M SESTAMIBI INJECTION, POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA078806
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-07-01

NDC 45548-141-30 [45548014130]

TECHNETIUM TC 99M SESTAMIBI INJECTION, POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA078806
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-07-01

Drug Details

Active Ingredients

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

OpenFDA Data

• SPL SET ID: 07c893fc-cfba-1d98-0232-6448463afb87
• Manufacturer:
  • Jubilant Draximage (USA) Inc.
• UNII:
  • 971Z4W1S09

Pharmacological Class

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

NDC Crossover Matching brand name "TECHNETIUM TC 99M SESTAMIBI" or generic name "Technetium Tc 99m Sestamibi"

NDC	Brand Name	Generic Name
45548-141	TECHNETIUM TC 99M SESTAMIBI	Technetium TC 99m Sestamibi
69945-092	Technetium Tc 99m Sestamibi	Technetium Tc 99m Sestamibi