Fludeoxyglucose

Orange BookUNIISPLATC V09IX04

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

Identification

ManufacturerThe Regents of the University of Michigan

CountryUS (United States)

ATC codeV09IX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7632600120
19 mL in 1 VIAL, GLASS (76326-001-20)

Annotations

UNII (FDA Substance ID)

0Z5B2CJX4D

FLUDEOXYGLUCOSE F-18

RxCUI 1362737

Orange Book

A204531

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": "76326-001_412331b1-c993-e524-e063-6294a90a444b",
  "productndc": "76326-001",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "204531",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20-300mCi/ML",
        "product_no": "001",
        "approval_date": "Jul 17, 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": "ANDA204531",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fludeoxyglucose F18",
  "start_marketing_date": "20150717",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code V09IX04.

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