Fludeoxyglucose F 18

Orange BookUNIISPLATC V09IX04

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

Identification

ManufacturerMassachusetts General Hospital

CountryUS (United States)

ATC codeV09IX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7631833450
50 mL in 1 VIAL (76318-334-50)

Annotations

UNII (FDA Substance ID)

0Z5B2CJX4D

FLUDEOXYGLUCOSE F-18

RxCUI 1362737

Orange Book

A204333

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": "76318-334_d6019460-717e-4285-9582-06646e8f778a",
  "productndc": "76318-334",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "204333",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20-300mCi/ML",
        "product_no": "001",
        "approval_date": "Sep 25, 2014"
      }
    ],
    "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": "ANDA204333",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fludeoxyglucose F-18",
  "start_marketing_date": "20111030",
  "active_numerator_strength": "300"
}

Related drugs

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