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United States · US · US:69488-003_74d44dec-f079-43b7-94ac-989a948f53ec
Lutathera
Orange BookUNIISPLATC V10XX04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Accelerator Applications USA, Inc
CountryUS (United States)
ATC codeV10XX04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169488003011 VIAL in 1 PACKAGE (69488-003-01) / 20.5 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
AE221IM3BB
LUTETIUM OXODOTREOTIDE LU-177
RxCUI 1999335
Orange Book
N208700
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "AE221IM3BB",
"rxcui": "1999335",
"inchikey": "MXDPZUIOZWKRAA-PRDSJKGBSA-K",
"display_name": "LUTETIUM OXODOTREOTIDE LU-177",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"72d1a024-00b7-418a-b36e-b2cb48f2ab55": {
"match": "brand_token",
"title": "LUTATHERA (LUTETIUM LU 177 DOTATATE) INJECTION [ADVANCED ACCELERATOR APPLICATIONS USA, INC]",
"spl_version": "12",
"published_date": "2026-01-16"
}
},
"productid": "69488-003_74d44dec-f079-43b7-94ac-989a948f53ec",
"productndc": "69488-003",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "208700",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "10mCi/ML",
"product_no": "001",
"approval_date": "Jan 26, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LUTETIUM OXODOTREOTIDE LU-177",
"proprietary_name": "Lutathera",
"active_ingred_unit": "mCi/mL",
"application_number": "NDA208700",
"marketing_category": "NDA",
"nonproprietary_name": "Lutetium Lu 177 dotatate",
"start_marketing_date": "20180126",
"active_numerator_strength": "10"
}Related drugs
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- ISLutatheraAdvanced Accelerator Applications
- DKLutatheraAdvanced Accelerator Application
- NOLutatheraAdvanced Accelerator Applications
- PLLutatheraAdvanced Accelerator Applications
- FILutatheraAdvanced Accelerator Applications
- CZLUTATHERAAdvanced Accelerator Applications, Rueil-Malmaison
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