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United States · US · US:76451-118_47434382-85a5-899c-e063-6294a90ad8d9

Fludeoxyglucose

Orange BookUNIISPLATC V09IX04

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

Identification

Manufacturer3D Imaging Drug Design and Development LLC
CountryUS (United States)
ATC codeV09IX04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7645111810
    10 mL in 1 VIAL, GLASS (76451-118-10)
  • ndc11
    7645111830
    30 mL in 1 VIAL, GLASS (76451-118-30)

Annotations

UNII (FDA Substance ID)
0Z5B2CJX4D
FLUDEOXYGLUCOSE F-18
RxCUI 1362737
Orange Book
A203778
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": "76451-118_47434382-85a5-899c-e063-6294a90ad8d9",
  "productndc": "76451-118",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "203778",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20-300mCi/ML",
        "product_no": "001",
        "approval_date": "Oct 30, 2015"
      }
    ],
    "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": "ANDA203778",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fludeoxyglucose F18",
  "start_marketing_date": "20120102",
  "active_numerator_strength": "300"
}

Related drugs

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