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United States · US · US:16729-542_23a8557b-45e6-e3cf-e063-6394a90a4b0d
Fluorouracil
Orange BookUNIISPLATC L01BC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAccord Healthcare Inc.
CountryUS (United States)
ATC codeL01BC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1116729542351 TUBE in 1 CARTON (16729-542-35) / 40 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
U3P01618RT
FLUOROURACIL
RxCUI 4492
Orange Book
A214845
AB
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": "TOPICAL",
"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": "16729-542_23a8557b-45e6-e3cf-e063-6394a90a4b0d",
"productndc": "16729-542",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "214845",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5%",
"product_no": "001",
"approval_date": "Oct 7, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUOROURACIL",
"proprietary_name": "Fluorouracil",
"active_ingred_unit": "mg/g",
"application_number": "ANDA214845",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluorouracil",
"start_marketing_date": "20211111",
"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
- 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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