NDC 54828-001

Neuraceq

Florbetaben F 18

Neuraceq is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Life Molecular Imaging, Sa. The primary component is Florbetaben F-18.

• Product ID: 54828-001_0ba79331-febc-4573-97d0-32b7e4c3044f
• NDC: 54828-001
• Product Type: Human Prescription Drug
• Proprietary Name: Neuraceq
• Generic Name: Florbetaben F 18
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2014-03-20
• Marketing Category: NDA / NDA
• Application Number: NDA204677
• Labeler Name: Life Molecular Imaging, SA
• Substance Name: FLORBETABEN F-18
• Active Ingredient Strength: 135 mCi/mL
• Pharm Classes: Radioactive Diagnostic Agent [EPC],Positron Emitting Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 54828-001-30

1 VIAL, MULTI-DOSE in 1 CONTAINER (54828-001-30) > 30 mL in 1 VIAL, MULTI-DOSE

• Marketing Start Date: 2014-03-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54828-001-30 [54828000130]

Neuraceq INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA204677
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-03-20

Drug Details

Active Ingredients

Ingredient	Strength
FLORBETABEN F-18	135 mCi/mL

Pharmacological Class

• Radioactive Diagnostic Agent [EPC]
• Positron Emitting Activity [MoA]