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 ID69932-001_939f8fbe-b736-45a0-8af3-2bb5d86aefaf
NDC69932-001
Product TypeHuman Prescription Drug
Proprietary NameAxumin
Generic NameFluciclovine F-18
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-05-27
Marketing CategoryNDA / NDA
Application NumberNDA208054
Labeler NameBlue Earth Diagnostics
Substance NameFLUCICLOVINE F-18
Active Ingredient Strength221 mCi/mL
Pharm ClassesRadioactive Diagnostic Agent [EPC],Positron Emitting Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69932-001-30

30 mL in 1 VIAL, MULTI-DOSE (69932-001-30)
Marketing Start Date2016-05-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69932-001-30 [69932000130]

Axumin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208054
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-27

Drug Details

Active Ingredients

IngredientStrength
FLUCICLOVINE F-18221 mCi/mL

OpenFDA Data

SPL SET ID:389a502e-a7d5-43dd-b6bf-f022ff23f3b9
Manufacturer
UNII

Pharmacological Class

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

Trademark Results [Axumin]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AXUMIN
AXUMIN
86554828 4986372 Live/Registered
Blue Earth Diagnostics Limited
2015-03-05

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