United States· US:45567-0755_334fde6d-c2c2-0054-e063-6394a90a26f0

Kit for the Preparation of Indium In 111 Pentetreotide

A medicinal product containing indium in-111 pentetreotide, registered in United States by Sun Pharmaceutical Industries, Inc..

Orange BookUS label

Checked against FDA National Drug Code directory (United States) on June 3, 2026

Informational only — not a medical device.

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The record

At a glance

FDA National Drug Code directory (United States)

Active substance: Indium In-111 Pentetreotide
Manufacturer: Sun Pharmaceutical Industries, 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 · 1

ndc11
4556707553
1 KIT in 1 KIT (45567-0755-3) * 1 mL in 1 VIAL (45567-0752-1) * 1 mL in 1 VIAL (45567-0753-1)

Regulatory notes

Orange Book

A212785

DailyMed SPL labels

1 version tracked

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/0e09bf24-01e3-4ad8-9549-d6ffe1ed12ab
GET /v1/drugs/0e09bf24-01e3-4ad8-9549-d6ffe1ed12ab?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": {
    "54608807-4df6-49ba-b065-59a19ef224c4": {
      "match": "brand_token",
      "title": "KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE (TECHNETIUM TC 99M MEDRONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CARDINAL HEALTH 414, LLC]",
      "spl_version": "5",
      "published_date": "2025-09-10"
    }
  },
  "productid": "45567-0755_334fde6d-c2c2-0054-e063-6394a90a26f0",
  "productndc": "45567-0755",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "212785",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "3mCi/ML",
        "product_no": "001",
        "approval_date": "Jul 1, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Kit for the Preparation of Indium In 111 Pentetreotide",
  "active_ingred_unit": null,
  "application_number": "ANDA212785",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Indium In-111 Pentetreotide",
  "start_marketing_date": "20250325",
  "active_numerator_strength": null
}

API reference MCP server Plans

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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.

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