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United States · US · US:70700-186_4b35b4f1-4de4-42de-e063-6294a90a10ae
Fluorouracil
Orange BookUNIISPLATC L01BC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerXiromed LLC
CountryUS (United States)
ATC codeL01BC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11707001862310 VIAL in 1 CARTON (70700-186-23) / 10 mL in 1 VIAL (70700-186-22)
Annotations
UNII (FDA Substance ID)
U3P01618RT
FLUOROURACIL
RxCUI 4492
Orange Book
A210123
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "U3P01618RT",
"rxcui": "4492",
"inchikey": "GHASVSINZRGABV-UHFFFAOYSA-N",
"display_name": "FLUOROURACIL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff": {
"match": "brand_token",
"title": "FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]",
"spl_version": "6",
"published_date": "2026-04-20"
}
},
"productid": "70700-186_4b35b4f1-4de4-42de-e063-6294a90a10ae",
"productndc": "70700-186",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "210123",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "500MG/10ML (50MG/ML)",
"product_no": "001",
"approval_date": "Oct 27, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "1GM/20ML (50MG/ML)",
"product_no": "002",
"approval_date": "Oct 27, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUOROURACIL",
"proprietary_name": "Fluorouracil",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA210123",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluorouracil",
"start_marketing_date": "20210813",
"active_numerator_strength": "50"
}Related drugs
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- CZ5-FLUOROURACIL EBEWEEBEWE Pharma Ges.m.b.H Nfg.KG, Unterach
- CZ5-FLUOROURACIL EBEWEEBEWE Pharma Ges.m.b.H Nfg.KG, Unterach
Access this data programmatically
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