Fludeoxyglucose F 18

Orange BookUNIISPLATC V09IX04

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

Identification

ManufacturerThe University of Utah DBA Cyclotron Radiochemistry Lab / Huntsman Cancer Institute

CountryUS (United States)

ATC codeV09IX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6793901050
50 mL in 1 VIAL, MULTI-DOSE (67939-010-50)

Annotations

UNII (FDA Substance ID)

0Z5B2CJX4D

FLUDEOXYGLUCOSE F-18

RxCUI 1362737

Orange Book

A204498

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": "67939-010_d93db56f-430e-5490-e053-2995a90ace22",
  "productndc": "67939-010",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "204498",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20-300mCi/ML",
        "product_no": "001",
        "approval_date": "Jun 23, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUDEOXYGLUCOSE F-18",
  "proprietary_name": "Fludeoxyglucose F 18",
  "active_ingred_unit": "mCi/mL",
  "application_number": "ANDA204498",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fludeoxyglucose F 18",
  "start_marketing_date": "20131101",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code V09IX04.

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