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 ID | 69488-003_0ba40472-2309-43f4-b7d9-f8b1bcfcab09 |
| NDC | 69488-003 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Lutathera |
| Generic Name | Lutetium Lu 177 Dotatate |
| Dosage Form | Injection |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2018-01-26 |
| Marketing Category | NDA / NDA |
| Application Number | NDA208700 |
| Labeler Name | Advanced Accelerator Applications USA, Inc |
| Substance Name | LUTETIUM OXODOTREOTIDE LU-177 |
| Active Ingredient Strength | 10 mCi/mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
Packaging
NDC 69488-003-01
1 VIAL in 1 PACKAGE (69488-003-01) > 20.5 mL in 1 VIAL
| Marketing Start Date | 2018-01-26 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 69488-003-01 [69488000301]
Lutathera INJECTION
| Marketing Category | NDA |
| Application Number | NDA208700 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-01-26 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| LUTETIUM OXODOTREOTIDE LU-177 | 10 mCi/mL |
OpenFDA Data
| SPL SET ID: | 72d1a024-00b7-418a-b36e-b2cb48f2ab55 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Trademark Results [Lutathera]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LUTATHERA 79101923 4196427 Live/Registered |
ADVANCED ACCELERATOR APPLICATIONS INTERN 2011-07-28 |
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