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United States · US · US:63323-117_e1f73bef-26d8-419c-96c1-a8f8aa201c63
Fluorouracil
Orange BookUNIISPLATC L01BC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeL01BC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1163323117511 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (63323-117-51) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
- ndc1163323117611 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (63323-117-61) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
Annotations
UNII (FDA Substance ID)
U3P01618RT
FLUOROURACIL
RxCUI 4492
Orange Book
A040278
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": "63323-117_e1f73bef-26d8-419c-96c1-a8f8aa201c63",
"productndc": "63323-117",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "040278",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "2.5GM/50ML (50MG/ML)",
"product_no": "001",
"approval_date": "Sep 30, 1998"
},
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "5GM/100ML (50MG/ML)",
"product_no": "002",
"approval_date": "Sep 30, 1998"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUOROURACIL",
"proprietary_name": "Fluorouracil",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA040278",
"marketing_category": "ANDA",
"nonproprietary_name": "FLUOROURACIL",
"start_marketing_date": "20000712",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code L01BC02.
- CZ5-FLUOROURACIL EBEWEEBEWE Pharma Ges.m.b.H Nfg.KG, Unterach
- CZ5-FLUOROURACIL EBEWEEBEWE Pharma Ges.m.b.H Nfg.KG, Unterach
- CZ5-FLUOROURACIL EBEWEEBEWE Pharma Ges.m.b.H Nfg.KG, Unterach
- CZ5-FLUOROURACIL EBEWEEBEWE Pharma Ges.m.b.H Nfg.KG, Unterach
- CZ5-FLUOROURACIL EBEWEEBEWE Pharma Ges.m.b.H Nfg.KG, Unterach
- CZ5-FLUOROURACIL EBEWEEBEWE Pharma Ges.m.b.H Nfg.KG, Unterach
- 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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