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United States · US · US:13267-234_6586ed67-0b87-4046-a7c1-274d39c10922

Fludeoxyglucose

Orange BookUNIISPLATC V09IX04

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

Identification

ManufacturerTHE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
CountryUS (United States)
ATC codeV09IX04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1326723445
    25 mL in 1 VIAL, GLASS (13267-234-45)

Annotations

UNII (FDA Substance ID)
0Z5B2CJX4D
FLUDEOXYGLUCOSE F-18
RxCUI 1362737
Orange Book
N021870
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "0Z5B2CJX4D",
    "rxcui": "1362737",
    "inchikey": "AOYNUTHNTBLRMT-MXWOLSILSA-N",
    "display_name": "FLUDEOXYGLUCOSE F-18",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "3535020f-26c3-40b8-bdb5-1aaa1857ba57": {
      "match": "brand_token",
      "title": "FLUDEOXYGLUCOSE F-18 INJECTION [PHARMALOGIC SOUTH CAROLINA, LLC]",
      "spl_version": "15",
      "published_date": "2026-05-25"
    }
  },
  "productid": "13267-234_6586ed67-0b87-4046-a7c1-274d39c10922",
  "productndc": "13267-234",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "021870",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Aug 19, 2005"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "20-400mCi/ML",
        "product_no": "002",
        "approval_date": "Nov 21, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUDEOXYGLUCOSE F-18",
  "proprietary_name": "Fludeoxyglucose",
  "active_ingred_unit": "mCi/mL",
  "application_number": "NDA021870",
  "marketing_category": "NDA",
  "nonproprietary_name": "Fludeoxyglucose F18",
  "start_marketing_date": "20050819",
  "active_numerator_strength": "400"
}

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