Kit for the Preparation of Indium In 111 Pentetreotide

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 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)

Annotations

Orange Book

A212785

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "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
}

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