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United States · US · US:65174-179_92a1bc37-cc23-4498-ad61-29347c3876dc

Kit for the Preparation of Technetium Tc 99m Sulfur Colloid

Orange BookSPL

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

Identification

ManufacturerJubilant DraxImage Inc., dba Jubilant Radiopharma
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6517417901
    1 KIT in 1 PACKAGE (65174-179-01) * 3 mL in 1 VIAL (65174-046-01) * 3 mL in 1 VIAL (65174-047-01) * 10 mL in 1 VIAL (65174-131-01)

Annotations

Orange Book
A213516
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "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": "65174-179_92a1bc37-cc23-4498-ad61-29347c3876dc",
  "productndc": "65174-179",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "213516",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "N/A",
        "product_no": "001",
        "approval_date": "Nov 9, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Kit for the Preparation of Technetium Tc 99m Sulfur Colloid",
  "active_ingred_unit": null,
  "application_number": "ANDA213516",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Technetium Tc 99m Sulfur Colloid Kit",
  "start_marketing_date": "20231204",
  "active_numerator_strength": null
}

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