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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

  • ndc11
    9920785002
    12 TUBE in 1 CARTON (99207-850-02) / 2 g in 1 TUBE
  • ndc11
    9920785060
    1 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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