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United States · US · US:69945-064_2d08d179-39bb-5cd0-e063-6394a90a8ab0

Detectnet

Orange BookUNIISPLATC V09IX15

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerCURIUM US LLC
CountryUS (United States)
ATC codeV09IX15
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6994506401
    1 VIAL, SINGLE-USE in 1 CAN (69945-064-01) / 4 mL in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)
N3858377KC
COPPER OXODOTREOTIDE CU-64
RxCUI 2396442
Orange Book
N213227
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "N3858377KC",
    "rxcui": "2396442",
    "inchikey": "IJRLLVFQGCCPPI-NVGRTJHCSA-L",
    "display_name": "COPPER OXODOTREOTIDE CU-64",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "f898c8a7-beb7-4318-a8ea-6f058d69342b": {
      "match": "brand_token",
      "title": "DETECTNET (COPPER CU 64 DOTATATE) INJECTION, SOLUTION [CURIUM US LLC]",
      "spl_version": "5",
      "published_date": "2025-02-03"
    }
  },
  "productid": "69945-064_2d08d179-39bb-5cd0-e063-6394a90a8ab0",
  "productndc": "69945-064",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "213227",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4mL (1mCi/ML)",
        "product_no": "001",
        "approval_date": "Sep 3, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COPPER OXODOTREOTIDE CU-64",
  "proprietary_name": "Detectnet",
  "active_ingred_unit": "mCi/mL",
  "application_number": "NDA213227",
  "marketing_category": "NDA",
  "nonproprietary_name": "copper Cu 64 Dotatate",
  "start_marketing_date": "20200914",
  "active_numerator_strength": "1"
}

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