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United States · US · US:69864-001_c961907a-db84-c6f2-e053-2995a90aefd2

Fludeoxyglucose F18

Orange BookUNIISPLATC V09IX04

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

Identification

ManufacturerThe Methodist Hospital Research Institute
CountryUS (United States)
ATC codeV09IX04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6986400130
    30 mL in 1 VIAL, MULTI-DOSE (69864-001-30)

Annotations

UNII (FDA Substance ID)
0Z5B2CJX4D
FLUDEOXYGLUCOSE F-18
RxCUI 1362737
Orange Book
A203904
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": "69864-001_c961907a-db84-c6f2-e053-2995a90aefd2",
  "productndc": "69864-001",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "203904",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20-300mCi/ML",
        "product_no": "001",
        "approval_date": "Apr 23, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUDEOXYGLUCOSE F-18",
  "proprietary_name": "Fludeoxyglucose F18",
  "active_ingred_unit": "Ci/mL",
  "application_number": "ANDA203904",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fludeoxyglucose F18",
  "start_marketing_date": "20120423",
  "active_numerator_strength": ".3"
}

Related drugs

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