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United States · US · US:25021-215_223c5d8d-c064-4a0a-8490-b1c4aa0e706d
fluorouracil
Orange BookUNIISPLATC L01BC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeL01BC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1125021215981 BOTTLE in 1 CARTON (25021-215-98) / 50 mL in 1 BOTTLE
- ndc1125021215991 BOTTLE in 1 CARTON (25021-215-99) / 100 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
U3P01618RT
FLUOROURACIL
RxCUI 4492
Orange Book
A203609
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": "25021-215_223c5d8d-c064-4a0a-8490-b1c4aa0e706d",
"productndc": "25021-215",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "203609",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "2.5GM/50ML (50MG/ML)",
"product_no": "001",
"approval_date": "Feb 17, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "5GM/100ML (50MG/ML)",
"product_no": "002",
"approval_date": "Feb 17, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUOROURACIL",
"proprietary_name": "fluorouracil",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA203609",
"marketing_category": "ANDA",
"nonproprietary_name": "fluorouracil",
"start_marketing_date": "20160915",
"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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