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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

  • ndc11
    6948800140
    1 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
}

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