Fludeoxyglucose F-18

Orange BookUNIISPLATC V09IX04

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

Identification

ManufacturerPrecision Nuclear, LLC

CountryUS (United States)

ATC codeV09IX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5276800130
1 VIAL, MULTI-DOSE in 1 CARTON (52768-001-30) / 30 mL in 1 VIAL, MULTI-DOSE
ndc11
5276800150
1 VIAL, MULTI-DOSE in 1 CARTON (52768-001-50) / 50 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)

0Z5B2CJX4D

FLUDEOXYGLUCOSE F-18

RxCUI 1362737

Orange Book

A204546

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": "52768-001_34048aac-62bc-4f71-8592-5d685e2a0da5",
  "productndc": "52768-001",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "204546",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20-500mCi/ML",
        "product_no": "001",
        "approval_date": "Apr 7, 2015"
      }
    ],
    "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": "ANDA204546",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FLUDEOXYGLUCOSE F-18",
  "start_marketing_date": "20101010",
  "active_numerator_strength": "500"
}

Related drugs

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