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United States · US · US:13267-346_f8d69c66-d9aa-4bb8-bb56-5bebeef87af5

Fluorodopa

Orange BookUNIIATC V09IX05

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

Identification

ManufacturerTHE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH
CountryUS (United States)
ATC codeV09IX05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1326734657
    30 mL in 1 VIAL, GLASS (13267-346-57)

Annotations

UNII (FDA Substance ID)
2C598205QX
FLUORODOPA F-18
RxCUI 2571853
Orange Book
N200655
Raw payload (JSON)
{
  "unii": {
    "unii": "2C598205QX",
    "rxcui": "2571853",
    "inchikey": "PAXWQORCRCBOCU-RPDRGXCHSA-N",
    "display_name": "FLUORODOPA F-18",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "productid": "13267-346_f8d69c66-d9aa-4bb8-bb56-5bebeef87af5",
  "productndc": "13267-346",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "200655",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1-40mCi/ML",
        "product_no": "001",
        "approval_date": "Oct 10, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUORODOPA F-18",
  "proprietary_name": "Fluorodopa",
  "active_ingred_unit": "mCi/mL",
  "application_number": "NDA200655",
  "marketing_category": "NDA",
  "nonproprietary_name": "Fluorodopa F18",
  "start_marketing_date": "20191010",
  "active_numerator_strength": "40"
}

Related drugs

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