NDC 0002-1200

Amyvid

Florbetapir F 18

Amyvid is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Eli Lilly And Company. The primary component is Florbetapir F-18.

• Product ID: 0002-1200_35551a38-7a8d-43b8-8abd-f6cb7549e932
• NDC: 0002-1200
• Product Type: Human Prescription Drug
• Proprietary Name: Amyvid
• Generic Name: Florbetapir F 18
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2012-06-01
• Marketing Category: NDA / NDA
• Application Number: NDA202008
• Labeler Name: Eli Lilly and Company
• Substance Name: FLORBETAPIR F-18
• Active Ingredient Strength: 51 mCi/mL
• Pharm Classes: Radioactive Diagnostic Agent [EPC],Positron Emitting Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0002-1200-30

1 VIAL, MULTI-DOSE in 1 CAN (0002-1200-30) > 30 mL in 1 VIAL, MULTI-DOSE

• Marketing Start Date: 2012-06-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0002-1200-30 [00002120030]

Amyvid INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA202008
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-06-01

NDC 0002-1200-50 [00002120050]

Amyvid INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA202008
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-06-01

NDC 0002-1200-10 [00002120010]

Amyvid INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA202008
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-06-01
• Marketing End Date: 2016-06-10

Drug Details

Active Ingredients

Ingredient	Strength
FLORBETAPIR F-18	51 mCi/mL

OpenFDA Data

• SPL SET ID: bb5a5043-0f51-11df-8a39-0800200c9a66
• Manufacturer:
  • Eli Lilly and Company
• UNII:
  • 6W15Z5R0RU

Pharmacological Class

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