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United States · US · US:60215-411_4041af0a-011f-ddc6-e063-6394a90af478

Fludeoxyglucose

Orange BookUNIISPLATC V09IX04

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

Identification

ManufacturerThe University of Texas MD Anderson Cancer Center
CountryUS (United States)
ATC codeV09IX04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6021541130
    27 mL in 1 VIAL, GLASS (60215-411-30)

Annotations

UNII (FDA Substance ID)
0Z5B2CJX4D
FLUDEOXYGLUCOSE F-18
RxCUI 1362737
Orange Book
A203246
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": "60215-411_4041af0a-011f-ddc6-e063-6394a90af478",
  "productndc": "60215-411",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "203246",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20-150mCi/ML",
        "product_no": "001",
        "approval_date": "Jan 13, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20-300mCi/ML",
        "product_no": "002",
        "approval_date": "Jan 13, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUDEOXYGLUCOSE F-18",
  "proprietary_name": "Fludeoxyglucose",
  "active_ingred_unit": "mCi/mL",
  "application_number": "ANDA203246",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fludeoxyglucose F18",
  "start_marketing_date": "20111206",
  "active_numerator_strength": "300"
}

Related drugs

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