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United States · US · US:69864-001_c961907a-db84-c6f2-e053-2995a90aefd2
Fludeoxyglucose F18
Orange BookUNIISPLATC V09IX04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerThe Methodist Hospital Research Institute
CountryUS (United States)
ATC codeV09IX04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11698640013030 mL in 1 VIAL, MULTI-DOSE (69864-001-30)
Annotations
UNII (FDA Substance ID)
0Z5B2CJX4D
FLUDEOXYGLUCOSE F-18
RxCUI 1362737
Orange Book
A203904
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": "69864-001_c961907a-db84-c6f2-e053-2995a90aefd2",
"productndc": "69864-001",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "203904",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "20-300mCi/ML",
"product_no": "001",
"approval_date": "Apr 23, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUDEOXYGLUCOSE F-18",
"proprietary_name": "Fludeoxyglucose F18",
"active_ingred_unit": "Ci/mL",
"application_number": "ANDA203904",
"marketing_category": "ANDA",
"nonproprietary_name": "Fludeoxyglucose F18",
"start_marketing_date": "20120423",
"active_numerator_strength": ".3"
}Related drugs
Other records sharing ATC code V09IX04.
- CZ(18F)FDG-FRAlliance Medical RP Berlin GmbH, Berlin
- NL[18F]FDG Alliance Medical 300-3100 MBq/ml oplossing voor injectieAlliance Medical RP Berlin GmbH
- CA[F-18]-FLUDEOXYGLUCOSE (FDG) INJECTIONSYLVIA FEDORUK CANADIAN CENTRE FOR NUCLEAR INNOVATION
- NL18F-FDG Hoboken 250 MBq/ml, oplossing voor injectieTheranostics Erasmus MC B.V.
- CA18F-FLUDEOXYGLUCOSE (18F-FDG)ISOLOGIC INNOVATIVE RADIOPHARMACEUTICALS LTD.
- CZ2-[18F]-FDGRadioMedic s.r.o., Husinec-Řež
- CZ2-[18F]-FDGRadioMedic s.r.o., Husinec-Řež
- CZ2-[18F]-FDGRadioMedic s.r.o., Husinec-Řež
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