NDC 17156-022

CERETEC

Technetium Tc-99m Exametazime

CERETEC is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Medi-physics Inc. Dba Ge Healthcare.. The primary component is Technetium Tc-99m Exametazime.

• Product ID: 17156-022_b8cde30d-83ae-4c5f-bd9a-095d34118dbb
• NDC: 17156-022
• Product Type: Human Prescription Drug
• Proprietary Name: CERETEC
• Generic Name: Technetium Tc-99m Exametazime
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1988-12-30
• Marketing Category: NDA / NDA
• Application Number: NDA019829
• Labeler Name: Medi-Physics Inc. dba GE Healthcare.
• Substance Name: TECHNETIUM TC-99M EXAMETAZIME
• Active Ingredient Strength: 1 mg/5mL
• Pharm Classes: Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 17156-022-05

5 VIAL in 1 TRAY (17156-022-05) > 5 mL in 1 VIAL

• Marketing Start Date: 1988-12-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 17156-022-05 [17156002205]

CERETEC INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA019829
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1988-12-30

Drug Details

Active Ingredients

Ingredient	Strength
TECHNETIUM TC-99M EXAMETAZIME	.5 mg/5mL

OpenFDA Data

• SPL SET ID: 3c1eca7e-57a0-4876-8ed6-cd655ef5e296
• Manufacturer:
  • Medi-Physics Inc. dba GE Healthcare.
• UNII:
  • 3B744AG22N

Pharmacological Class

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

NDC Crossover Matching brand name "CERETEC" or generic name "Technetium Tc-99m Exametazime"

NDC	Brand Name	Generic Name
17156-022	CERETEC	TECHNETIUM TC-99M EXAMETAZIME
17156-023	Ceretec	Exametazime
17156-025	Ceretec	Technetium Tc-99m Exametazime and Cobaltous Chloride