Cardiolite

Orange BookUNII

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 · 2

ndc11
1199400120
20 VIAL in 1 BOX (11994-001-20) / 5 mL in 1 VIAL
ndc11
1199400155
5 VIAL in 1 BOX (11994-001-55) / 5 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

N6OU7HJ70P

TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE

RxCUI 1306061

Orange Book

N019785

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",
  "productid": "11994-001_d515f49a-8eb4-42f3-a7ee-1634a4804ca5",
  "productndc": "11994-001",
  "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": "Cardiolite",
  "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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