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United States · US · US:45548-141_b089044e-6c93-4941-94e7-55786e5b57b8

TECHNETIUM TC 99M SESTAMIBI

In shortageOrange BookUNIISPLATC V09GA01

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

Identification

ManufacturerJubilant Draximage (USA) Inc.
CountryUS (United States)
ATC codeV09GA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4554814105
    5 VIAL in 1 KIT (45548-141-05) / 10 mL in 1 VIAL
  • ndc11
    4554814110
    10 VIAL in 1 KIT (45548-141-10) / 10 mL in 1 VIAL
  • ndc11
    4554814130
    30 VIAL in 1 KIT (45548-141-30) / 10 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
971Z4W1S09
TECHNETIUM TC-99M SESTAMIBI
RxCUI 1482913
Orange Book
A078806
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": "INTRAVENOUS",
  "spl_meta": {
    "3c91d0d8-6cc5-834c-bda0-aa83a873b9fb": {
      "match": "brand_token",
      "title": "TECHNETIUM TC 99M MEDRONATE INJECTION, POWDER, FOR SOLUTION [JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA]",
      "spl_version": "4",
      "published_date": "2025-06-13"
    }
  },
  "productid": "45548-141_b089044e-6c93-4941-94e7-55786e5b57b8",
  "productndc": "45548-141",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "078806",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "N/A",
        "product_no": "001",
        "approval_date": "Apr 29, 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": "TECHNETIUM TC 99M SESTAMIBI",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA078806",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Technetium TC 99m Sestamibi",
  "start_marketing_date": "20090701",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code V09GA01.

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