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

ILLUCCIX

A medicinal product containing kit for the preparation of gallium ga 68 gozetotide injection, registered in United States by Telix Pharmaceuticals (US) Inc..

Orange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedILLUCCIXATC—REGISTER NO.US:74725-100_4690876d…PACKS LISTED2CHECKEDJune 3, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Kit for the preparation of gallium Ga 68 gozetotide injection
Manufacturer
Telix Pharmaceuticals (US) Inc.
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 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)

Regulatory notes

Orange Book
N214032
DailyMed SPL labels
1 version tracked

Same medicine, other countries

Kit for the preparation of gallium ga 68 gozetotide injection in 2 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All kit for the preparation of gallium ga 68 gozetotide injection products

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/7c98ce10-917b-4320-843f-4e2806f4be11
GET /v1/drugs/7c98ce10-917b-4320-843f-4e2806f4be11?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "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
}

See everything about kit for the preparation of gallium ga 68 gozetotide injection.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.