NDC 69488-003

Lutathera

Lutetium Lu 177 Dotatate

Lutathera is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Advanced Accelerator Applications Usa, Inc. The primary component is Lutetium Oxodotreotide Lu-177.

Product ID69488-003_0ba40472-2309-43f4-b7d9-f8b1bcfcab09
NDC69488-003
Product TypeHuman Prescription Drug
Proprietary NameLutathera
Generic NameLutetium Lu 177 Dotatate
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-01-26
Marketing CategoryNDA / NDA
Application NumberNDA208700
Labeler NameAdvanced Accelerator Applications USA, Inc
Substance NameLUTETIUM OXODOTREOTIDE LU-177
Active Ingredient Strength10 mCi/mL
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 69488-003-01

1 VIAL in 1 PACKAGE (69488-003-01) > 20.5 mL in 1 VIAL
Marketing Start Date2018-01-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69488-003-01 [69488000301]

Lutathera INJECTION
Marketing CategoryNDA
Application NumberNDA208700
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-01-26

Drug Details

Active Ingredients

IngredientStrength
LUTETIUM OXODOTREOTIDE LU-17710 mCi/mL

OpenFDA Data

SPL SET ID:72d1a024-00b7-418a-b36e-b2cb48f2ab55
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1999687
  • 1999682

  • Trademark Results [Lutathera]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LUTATHERA
    LUTATHERA
    79101923 4196427 Live/Registered
    ADVANCED ACCELERATOR APPLICATIONS INTERN
    2011-07-28

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