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United States · US · US:65857-500_a5589464-e5bb-47b5-8a0c-372df1d7aed5

Kit for the Preparation of Technetium Tc99m Sestamibi

In shortageOrange BookUNIISPLATC V09GA01

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

Identification

ManufacturerCardinal Health 414, LLC
CountryUS (United States)
ATC codeV09GA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6585750020
    20 VIAL in 1 CARTON (65857-500-20) / 5 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
971Z4W1S09
TECHNETIUM TC-99M SESTAMIBI
RxCUI 1482913
Orange Book
A078809
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Technetium TC-99M Pyrophosphate Kit Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "971Z4W1S09",
    "rxcui": "1482913",
    "inchikey": "ZBTQTVSNLRPJHI-UHFFFAOYSA-N",
    "display_name": "TECHNETIUM TC-99M SESTAMIBI",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "PARENTERAL",
  "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": "65857-500_a5589464-e5bb-47b5-8a0c-372df1d7aed5",
  "productndc": "65857-500",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "078809",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "N/A",
        "product_no": "001",
        "approval_date": "Apr 28, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TECHNETIUM TC-99M SESTAMIBI",
  "shortage_reason": "Technetium TC-99M Pyrophosphate Kit Injection",
  "shortage_status": "current",
  "proprietary_name": "Kit for the Preparation of Technetium Tc99m Sestamibi",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA078809",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Kit for the Preparation of Technetium Tc99m Sestamibi",
  "start_marketing_date": "20100601",
  "active_numerator_strength": "1"
}

Related drugs

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