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United States · US · US:74725-100_4690876d-42c7-b339-e063-6394a90aea4b

ILLUCCIX

Orange BookSPL

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

Identification

ManufacturerTelix Pharmaceuticals (US) Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7472510025
    1 KIT in 1 CARTON (74725-100-25) * 2.5 mL in 1 VIAL, MULTI-DOSE (74725-102-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (74725-103-64) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE (74725-101-25)
  • ndc11
    7472510064
    1 KIT in 1 CARTON (74725-100-64) * 2.5 mL in 1 VIAL, MULTI-DOSE (74725-102-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (74725-103-64) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE (74725-101-25)

Annotations

Orange Book
N214032
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": "INTRAVENOUS",
  "spl_meta": {
    "d4643b31-9b4f-673f-e053-2a95a90a559d": {
      "match": "brand_token",
      "title": "ILLUCCIX (KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE INJECTION) KIT [TELIX PHARMACEUTICALS (US) INC.]",
      "spl_version": "15",
      "published_date": "2025-12-23"
    }
  },
  "productid": "74725-100_4690876d-42c7-b339-e063-6394a90aea4b",
  "productndc": "74725-100",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "214032",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "N/A",
        "product_no": "001",
        "approval_date": "Dec 17, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "ILLUCCIX",
  "active_ingred_unit": null,
  "application_number": "NDA214032",
  "marketing_category": "NDA",
  "nonproprietary_name": "Kit for the preparation of gallium Ga 68 gozetotide injection",
  "start_marketing_date": "20211217",
  "active_numerator_strength": null
}

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