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United States · US · US:80725-143_497f8d4c-3d59-43d3-93ee-6bdbc391b457
Eulexin
Orange BookUNIISPLATC L02BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWaylis Therapeutics LLC
CountryUS (United States)
ATC codeL02BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1180725143181 BOTTLE, PLASTIC in 1 BOX (80725-143-18) / 180 CAPSULE in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
76W6J0943E
FLUTAMIDE
RxCUI 4508
Orange Book
A075298
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "76W6J0943E",
"rxcui": "4508",
"inchikey": "MKXKFYHWDHIYRV-UHFFFAOYSA-N",
"display_name": "FLUTAMIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"0a905e25-42b6-4937-a689-f01a8f22e644": {
"match": "brand_token",
"title": "EULEXIN (FLUTAMIDE) CAPSULE [WAYLIS THERAPEUTICS LLC]",
"spl_version": "2",
"published_date": "2025-02-10"
}
},
"productid": "80725-143_497f8d4c-3d59-43d3-93ee-6bdbc391b457",
"productndc": "80725-143",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "075298",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "125MG",
"product_no": "001",
"approval_date": "Sep 18, 2001"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUTAMIDE",
"proprietary_name": "Eulexin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075298",
"marketing_category": "ANDA",
"nonproprietary_name": "Flutamide",
"start_marketing_date": "20211112",
"active_numerator_strength": "125"
}Related drugs
Other records sharing ATC code L02BB01.
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