NDC 69932-001

Axumin

Fluciclovine F-18

Axumin is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Blue Earth Diagnostics. The primary component is Fluciclovine F-18.

• Product ID: 69932-001_939f8fbe-b736-45a0-8af3-2bb5d86aefaf
• NDC: 69932-001
• Product Type: Human Prescription Drug
• Proprietary Name: Axumin
• Generic Name: Fluciclovine F-18
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-05-27
• Marketing Category: NDA / NDA
• Application Number: NDA208054
• Labeler Name: Blue Earth Diagnostics
• Substance Name: FLUCICLOVINE F-18
• Active Ingredient Strength: 221 mCi/mL
• Pharm Classes: Radioactive Diagnostic Agent [EPC],Positron Emitting Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69932-001-30

30 mL in 1 VIAL, MULTI-DOSE (69932-001-30)

• Marketing Start Date: 2016-05-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69932-001-30 [69932000130]

Axumin INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA208054
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-05-27

Drug Details

Active Ingredients

Ingredient	Strength
FLUCICLOVINE F-18	221 mCi/mL

OpenFDA Data

• SPL SET ID: 389a502e-a7d5-43dd-b6bf-f022ff23f3b9
• Manufacturer:
  • Blue Earth Diagnostics
• UNII:
  • 38R1Q0L1ZE

Pharmacological Class

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