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United States · US · US:17156-024_cfb49f93-c931-4429-8a04-d3c6d1e913a0

Myoview

Orange BookUNIISPL

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

Identification

ManufacturerMedi-Physics Inc. dba GE Healthcare
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1715602405
    5 VIAL in 1 KIT (17156-024-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Annotations

UNII (FDA Substance ID)
3J0KPB596Q
TETROFOSMIN
RxCUI 1311569
Orange Book
N020372
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "3J0KPB596Q",
    "rxcui": "1311569",
    "inchikey": "QCWJONLQSHEGEJ-UHFFFAOYSA-N",
    "display_name": "TETROFOSMIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "98c85037-a907-4a3a-8864-c3a5298b4759": {
      "match": "brand_token",
      "title": "MYOVIEW (TETROFOSMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEDI-PHYSICS INC. DBA GE HEALTHCARE]",
      "spl_version": "9",
      "published_date": "2024-01-12"
    }
  },
  "productid": "17156-024_cfb49f93-c931-4429-8a04-d3c6d1e913a0",
  "productndc": "17156-024",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "020372",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "N/A",
        "product_no": "001",
        "approval_date": "Feb 9, 1996"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "N/A",
        "product_no": "002",
        "approval_date": "Jul 7, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TETROFOSMIN",
  "proprietary_name": "Myoview",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020372",
  "marketing_category": "NDA",
  "nonproprietary_name": "Tetrofosmin",
  "start_marketing_date": "19960209",
  "active_numerator_strength": ".23"
}

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