Fludeoxyglucose F-18

Orange BookUNIISPLATC V09IX04

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

Identification

ManufacturerCardinal Health 414, LLC

CountryUS (United States)

ATC codeV09IX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6585715030
30 mL in 1 VIAL, GLASS (65857-150-30)

Annotations

UNII (FDA Substance ID)

0Z5B2CJX4D

FLUDEOXYGLUCOSE F-18

RxCUI 1362737

Orange Book

A203603

APAP

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": "65857-150_41abd652-7741-45e9-89a8-535a91d57f51",
  "productndc": "65857-150",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "203603",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20-300mCi/ML",
        "product_no": "001",
        "approval_date": "Nov 13, 2015"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "20-500mCi/ML",
        "product_no": "002",
        "approval_date": "Sep 27, 2018"
      }
    ],
    "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": "ANDA203603",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fludeoxyglucose F-18",
  "start_marketing_date": "20190102",
  "active_numerator_strength": "500"
}

Related drugs

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