Kit for the Preparation of Technetium Tc99m Sestamibi

Orange BookUNIISPL

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

Identification

ManufacturerLantheus Medical Imaging, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1199400320
20 VIAL in 1 BOX (11994-003-20) / 5 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

N6OU7HJ70P

TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE

RxCUI 1306061

Orange Book

N019785

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "N6OU7HJ70P",
    "rxcui": "1306061",
    "inchikey": "WJRFSUVOHUMYAO-UHFFFAOYSA-N",
    "display_name": "TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "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": "11994-003_517b7337-3529-4948-8d02-b8e2cf97a161",
  "productndc": "11994-003",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "019785",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "N/A",
        "product_no": "001",
        "approval_date": "Dec 21, 1990"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "N/A",
        "product_no": "003",
        "approval_date": "May 23, 1997"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE",
  "proprietary_name": "Kit for the Preparation of Technetium Tc99m Sestamibi",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA019785",
  "marketing_category": "NDA",
  "nonproprietary_name": "TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE",
  "start_marketing_date": "19901220",
  "active_numerator_strength": "1"
}

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