NDC 17156-067

Vizamyl

Flutemetamol F-18

Vizamyl is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Medi-physics, Inc. Dba Ge Healthcare. The primary component is Flutemetamol F-18.

• Product ID: 17156-067_50246609-3b1c-47cd-9064-a600f51595c4
• NDC: 17156-067
• Product Type: Human Prescription Drug
• Proprietary Name: Vizamyl
• Generic Name: Flutemetamol F-18
• Dosage Form: Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2014-01-01
• Marketing Category: NDA / NDA
• Application Number: NDA203137
• Labeler Name: Medi-Physics, Inc. dba GE Healthcare
• Substance Name: FLUTEMETAMOL F-18
• Active Ingredient Strength: 4 mCi/mL
• Pharm Classes: Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 17156-067-30

1 VIAL, MULTI-DOSE in 1 CONTAINER (17156-067-30) > 30 mL in 1 VIAL, MULTI-DOSE

• Marketing Start Date: 2014-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 17156-067-10 [17156006710]

Vizamyl SOLUTION

• Marketing Category: NDA
• Application Number: NDA203137
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-03-01
• Marketing End Date: 2018-06-18

NDC 17156-067-30 [17156006730]

Vizamyl SOLUTION

• Marketing Category: NDA
• Application Number: NDA203137
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-03-01

Drug Details

Active Ingredients

Ingredient	Strength
FLUTEMETAMOL F-18	4.05 mCi/mL

OpenFDA Data

• SPL SET ID: b3558f16-8f9a-4e55-8d9c-836427ebaa57
• Manufacturer:
  • Medi-Physics, Inc. dba GE Healthcare
• UNII:
  • L49M066S0O

Pharmacological Class

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