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United States · US · US:69488-001_3a8e7db3-9df3-4957-809d-e194516874c0
NETSPOT
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Accelerator Applications USA, Inc
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169488001401 KIT in 1 KIT (69488-001-40) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Annotations
Orange Book
N208547
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "INTRAVENOUS",
"spl_meta": {
"b2b3be70-17d8-4093-896c-f1c54a2cf242": {
"match": "brand_token",
"title": "NETSPOT (68GA-DOTATATE) KIT [ADVANCED ACCELERATOR APPLICATIONS USA, INC]",
"spl_version": "22",
"published_date": "2026-01-16"
}
},
"productid": "69488-001_3a8e7db3-9df3-4957-809d-e194516874c0",
"productndc": "69488-001",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "208547",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "2.1-5.5mCi/ML",
"product_no": "001",
"approval_date": "Jun 1, 2016"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "NETSPOT",
"active_ingred_unit": null,
"application_number": "NDA208547",
"marketing_category": "NDA",
"nonproprietary_name": "68Ga-DOTATATE",
"start_marketing_date": "20160601",
"active_numerator_strength": null
}Access this data programmatically
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