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United States · US · US:99207-850_f18334bd-5ed1-43b2-87ba-80b803b54387
Luzu
Orange BookUNIISPLATC D01AC18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBausch Health US, LLC
CountryUS (United States)
ATC codeD01AC18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11992078500212 TUBE in 1 CARTON (99207-850-02) / 2 g in 1 TUBE
- ndc1199207850601 TUBE in 1 CARTON (99207-850-60) / 60 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
RE91AN4S8G
LULICONAZOLE
RxCUI 1482680
Orange Book
N204153
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "RE91AN4S8G",
"rxcui": "1482680",
"inchikey": "YTAOBBFIOAEMLL-REQDGWNSSA-N",
"display_name": "LULICONAZOLE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"a7016010-ce43-4c09-8d21-aeb697ffed31": {
"match": "brand_token",
"title": "LUZU (LULICONAZOLE) CREAM [BAUSCH HEALTH US, LLC]",
"spl_version": "13",
"published_date": "2025-09-03"
}
},
"productid": "99207-850_f18334bd-5ed1-43b2-87ba-80b803b54387",
"productndc": "99207-850",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "204153",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1%",
"product_no": "001",
"approval_date": "Nov 14, 2013"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LULICONAZOLE",
"proprietary_name": "Luzu",
"active_ingred_unit": "mg/g",
"application_number": "NDA204153",
"marketing_category": "NDA",
"nonproprietary_name": "LULICONAZOLE",
"start_marketing_date": "20131114",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code D01AC18.
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